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Trial record 43 of 48 for:    ( Map: Gabon )

Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa

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ClinicalTrials.gov Identifier: NCT00866619
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
The PATH Malaria Vaccine Initiative (MVI)
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Malaria
Interventions Biological: Malaria Vaccine 257049
Biological: Meningococcal C Conjugate Vaccine
Biological: Cell-culture rabies vaccine
Biological: TritanrixHepB/Hib
Biological: Polio Sabin Oral Polio Vaccine (GSK)
Enrollment 15459
Recruitment Details The study included 3 phases, a primary (PRI) phase (Months 0-3) and a booster (BST) phase at Month 20, each followed by a related PRI/BST efficacy, immunogenicity and safety (EIS) follow-up (FU) phase, and an EIS extension, from Month 32 to the median of Month 48 or Month 38 time point.
Pre-assignment Details Screening included the following: check for inclusion/exclusion criteria, vaccination contraindications/precautions, subjects’ medical history and signing informed consent forms.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid. Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally. Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid. Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Period Title: Overall Study
Started 5948 4358 2974 2179
Completed 4102 3088 2085 1549
Not Completed 1846 1270 889 630
Reason Not Completed
Adverse Event             112             106             47             44
Protocol Violation             2             39             2             17
Withdrawal by Subject             587             295             272             144
Lost to Follow-up             1145             830             568             425
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group Total
Hide Arm/Group Description Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid. Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally. Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid. Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally. Total of all reporting groups
Overall Number of Baseline Participants 5948 4358 2974 2179 15459
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 5948 participants 4358 participants 2974 participants 2179 participants 15459 participants
10.6  (3.8) 1.2  (0.4) 10.6  (3.7) 1.2  (0.4) 6.6  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5948 participants 4358 participants 2974 participants 2179 participants 15459 participants
Female
2967
  49.9%
2124
  48.7%
1503
  50.5%
1100
  50.5%
7694
  49.8%
Male
2981
  50.1%
2234
  51.3%
1471
  49.5%
1079
  49.5%
7765
  50.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
African heritage/African American Number Analyzed 5948 participants 4358 participants 2974 participants 2179 participants 15459 participants
5948
 100.0%
4358
 100.0%
2974
 100.0%
2179
 100.0%
15459
 100.0%
1.Primary Outcome
Title Rate of First or Only Clinical Episode of Plasmodium Falciparum (P. Falciparum) Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD)
Hide Description A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia was greater than (>) 5000 parasites per microliter (µL) accompanied by the presence of fever [axillary temperature greater than or equal to (≥) 37.5°C] at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 5-17 months age category.
Time Frame From Month 2.5 to Month 14
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) population for efficacy, which included all children aged 5-17 Months who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [5-17M] Group VeroRab Comparator [5-17M] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Overall Number of Participants Analyzed 2830 1466
Measure Type: Number
Unit of Measure: events per person-year
0.435 0.833
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK257049 [5-17M] Group, VeroRab Comparator [5-17M] Group
Comments The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus [Hazard Ratio (HR) in GSK257049 [5-17M] Group (HR1) divided by HR in control VeroRab Comparator [5-17M] Group (HR2)]; i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority
Comments Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 55.8
Confidence Interval (2-Sided) 97.5%
50.6 to 60.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD)
Hide Description A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia > 5000 parasites/µL was accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is, person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 6-12 weeks (6-12W) age category.
Time Frame From Month 2.5 to Month 14
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children aged 6-12 Weeks who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 3995 2008
Measure Type: Number
Unit of Measure: events per person-year
0.367 0.484
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK257049 [6-12W] Group, Menjugate Comparator [6-12W] Group
Comments The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus [Hazard Ratio (HR) in GSK257049 [6-12W] Group (HR1) divided by HR in control Menjugate Comparator [6-12W] Group (HR2)]; i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority
Comments Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 31.315
Confidence Interval (2-Sided) 97.5%
23.556 to 38.286
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Rate of All Episodes of P. Falciparum Clinical Malaria Infection (CPFMI) of PCD and of Secondary Case Definitions (SCD) 1, SCD 2 and SCD 3
Hide Description PCD=malaria episode with P. falciparum asexual parasitemia (PFAP) > 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease. SCD1=malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2=malaria episode with PFAP > 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3=malaria episode with PFAP > 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
Time Frame From Month 2.5 to Month 14
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2830 3995 1466 2008
Measure Type: Number
Unit of Measure: events per person-year
PCD 0.735 0.639 1.468 0.908
SCD1 1.224 0.989 2.312 1.403
SCD2 0.847 0.736 1.628 1.031
SCD3 0.625 0.515 1.244 0.731
4.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center
Hide Description PCD = malaria episode with PFAP > 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease (see below endpoints on severe malaria for details). Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are by center and across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
Time Frame From Month 2.5 to Month 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 4557 3996 2328 2007
Measure Type: Number
Unit of Measure: events per person-year
PCD – Agogo Number Analyzed 371 participants 418 participants 192 participants 221 participants
0.56 0.64 1.16 0.79
PCD – Bagamoyo Number Analyzed 462 participants 502 participants 235 participants 244 participants
0.1 0.08 0.28 0.14
PCD – Kilifi Number Analyzed 336 participants 186 participants 171 participants 102 participants
0.01 0.04 0.04 0.02
PCD – Kintampo Number Analyzed 602 participants 199 participants 296 participants 99 participants
1.01 1.53 1.85 1.49
PCD – Kombewa Number Analyzed 609 participants 387 participants 311 participants 196 participants
1.21 0.94 1.87 1.32
PCD – Korogwe Number Analyzed 568 participants 382 participants 293 participants 183 participants
0.04 0.03 0.11 0.05
PCD – Lambarene Number Analyzed 380 participants 147 participants 196 participants 62 participants
0.11 0.11 0.2 0.12
PCD – Lilongwe Number Analyzed 359 participants 500 participants 183 participants 258 participants
0.2 0.3 0.32 0.5
PCD – Manhica Number Analyzed 0 participants 381 participants 0 participants 188 participants
0.1 0.12
PCD – Nanoro Number Analyzed 389 participants 441 participants 198 participants 225 participants
1.42 1.93 2.4 2.39
PCD – Siaya Number Analyzed 481 participants 453 participants 253 participants 229 participants
2.01 2.03 3.31 2.75
PCD – Across Number Analyzed 4557 participants 3996 participants 2328 participants 2007 participants
0.69 0.71 1.17 0.92
5.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of SCD1, SCD2 and SCD3 (Overall)
Hide Description SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2 = malaria episode with PFAP > 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3 = malaria episode with PFAP > 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
Time Frame From Month 2.5 to Month 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 4557 3996 2328 2007
Measure Type: Number
Unit of Measure: events per person-year
SCD1 1.09 1.09 1.78 1.42
SCD2 0.78 0.81 1.3 1.04
SCD3 0.59 0.58 1.01 0.76
6.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers
Hide Description CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.
Time Frame From Month 2.5 up to study End (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: events per person-year
PCD – Kilifi Number Analyzed 163 participants 172 participants 172 participants 90 participants 95 participants 102 participants
0.02 0.03 0.08 0.06 0.04 0.04
PCD – Korogwe Number Analyzed 286 participants 282 participants 293 participants 191 participants 191 participants 183 participants
0.04 0.05 0.1 0.05 0.07 0.09
PCD – Lambarene Number Analyzed 187 participants 196 participants 196 participants 72 participants 75 participants 62 participants
0.15 0.15 0.23 0.1 0.18 0.17
PCD – Bagamoyo Number Analyzed 228 participants 242 participants 236 participants 252 participants 249 participants 245 participants
0.16 0.21 0.27 0.08 0.11 0.15
PCD – Lilongwe Number Analyzed 176 participants 183 participants 185 participants 247 participants 250 participants 257 participants
0.09 0.2 0.23 0.25 0.29 0.42
PCD – Agogo Number Analyzed 188 participants 183 participants 191 participants 209 participants 209 participants 221 participants
0.59 0.73 1.01 0.59 0.77 0.84
PCD – Kombewa Number Analyzed 315 participants 301 participants 312 participants 195 participants 193 participants 196 participants
1.26 1.37 1.64 1.37 1.37 1.62
PCD – Kintampo Number Analyzed 299 participants 310 participants 301 participants 98 participants 101 participants 100 participants
1.11 1.31 1.71 1.65 1.71 1.69
PCD – Manhica Number Analyzed 0 participants 0 participants 0 participants 193 participants 187 participants 188 participants
0.18 0.14 0.2
PCD – Nanoro Number Analyzed 194 participants 195 participants 198 participants 217 participants 224 participants 224 participants
1.95 2.18 2.69 2.59 2.79 3.14
PCD – Siaya Number Analyzed 240 participants 242 participants 252 participants 221 participants 231 participants 229 participants
2.09 2.55 3.15 2.43 2.67 3.12
PCD – Across Number Analyzed 2276 participants 2306 participants 2336 participants 1985 participants 2005 participants 2007 participants
0.79 0.9 1.14 0.86 0.95 1.08
7.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1), Across Centers
Hide Description CPFMI of SCD1 = malaria episode with PFAP >0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
Time Frame From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: events per person-year
1.26 1.41 1.81 1.29 1.43 1.61
8.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), Across Centers
Hide Description CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP >0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
Time Frame From Booster at Month 20 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2017 2057 2050 1743 1788 1762
Measure Type: Number
Unit of Measure: events per person-year
PCD 0.87 1.03 1.1 1.01 1.21 1.23
SCD1 1.39 1.65 1.82 1.48 1.79 1.8
9.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD and SCD1, Across Centers
Hide Description CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
Time Frame From Month 33 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 1784 1838 1864 1516 1548 1546
Measure Type: Number
Unit of Measure: events per person-year
PCD Number Analyzed 1784 participants 1838 participants 1864 participants 1516 participants 1548 participants 1546 participants
1.01 1.1 1.1 1.18 1.31 1.29
SCD1 Number Analyzed 1784 participants 1838 participants 1864 participants 1516 participants 1547 participants 1546 participants
1.61 1.79 1.88 1.73 1.92 1.91
10.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers
Hide Description CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.
Time Frame From Month 2.5 to Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: events per person-year
PCD – Kilifi Number Analyzed 163 participants 172 participants 172 participants 90 participants 95 participants 102 participants
0.03 0.04 0.09 0.06 0.04 0.05
PCD – Korogwe Number Analyzed 286 participants 282 participants 293 participants 191 participants 191 participants 183 participants
0.04 0.03 0.08 0.02 0.06 0.06
PCD – Lambarene Number Analyzed 187 participants 196 participants 196 participants 72 participants 75 participants 62 participants
0.14 0.14 0.21 0.1 0.18 0.18
PCD – Bagamoyo Number Analyzed 228 participants 242 participants 236 participants 252 participants 249 participants 245 participants
0.13 0.19 0.31 0.08 0.11 0.15
PCD – Lilongwe Number Analyzed 176 participants 183 participants 185 participants 247 participants 250 participants 257 participants
0.11 0.22 0.29 0.27 0.32 0.47
PCD – Agogo Number Analyzed 188 participants 183 participants 191 participants 209 participants 209 participants 221 participants
0.59 0.75 1.15 0.56 0.72 0.86
PCD – Kombewa Number Analyzed 315 participants 301 participants 312 participants 195 participants 193 participants 196 participants
1.12 1.29 1.67 1.28 1.25 1.55
PCD – Kintampo Number Analyzed 299 participants 310 participants 301 participants 98 participants 101 participants 100 participants
1.08 1.17 1.87 1.52 1.6 1.6
PCD – Manhica Number Analyzed 0 participants 0 participants 0 participants 193 participants 187 participants 188 participants
0.15 0.12 0.15
PCD – Nanoro Number Analyzed 194 participants 195 participants 198 participants 217 participants 224 participants 224 participants
1.42 1.67 2.45 2.27 2.53 2.92
PCD – Siaya Number Analyzed 240 participants 242 participants 252 participants 221 participants 231 participants 229 participants
1.91 2.46 3.25 2.41 2.54 3.09
PCD – Across Number Analyzed 2276 participants 2306 participants 2336 participants 1985 participants 2005 participants 2007 participants
0.68 0.81 1.15 0.8 0.88 1.03
11.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1)
Hide Description CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).
Time Frame From Month 2.5 to Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: events per person-year
1.1 1.24 1.78 1.19 1.33 1.54
12.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)
Hide Description CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).
Time Frame From Booster at Month 20 up to Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2017 2057 2050 1743 1788 1762
Measure Type: Number
Unit of Measure: events per person-year
PCD 0.72 0.96 1.1 0.91 1.15 1.2
SCD1 1.14 1.48 1.74 1.35 1.72 1.74
13.Secondary Outcome
Title Percentage of Subjects With Severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, Across Centers
Hide Description SPFMI of PCD = PFMI > 5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. SPFMI of SCD2 = PFMI >0 with one or more severity marker and without co-morbidity diagnosis. SPFMI of SCD3 = PFMI >5000 parasites/μL, with one or more severity marker, and without co-morbidity or HIV. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia < 2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l < 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. Analysis was performed in a pooled manner across age categories. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
Time Frame From Month 2.5 up to the time when 250 subjects were diagnosed with severe malaria of PCD, SCD1, SCD2 and SCD3 (up to the Month 14 time point for each age category or date of booster dose, whichever occurred first)
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Hide Analysis Population Description
The analysis was performed, across age categories for which groups were pooled from the ATP population for efficacy. This included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 Group Comparator Group
Hide Arm/Group Description:
For the purpose of the analysis, GSK257049 [5-17M] and GSK257049 [6-12W] groups have been pooled into a single group.
For the purpose of the analysis, VeroRab Comparator [5-17M] and Menjugate Comparator [6-12W] groups have been pooled into a single group.
Overall Number of Participants Analyzed 8597 4364
Measure Type: Number
Unit of Measure: Percentage of subjects
PCD 0.019 0.03
SCD1 0.023 0.036
SCD2 0.023 0.034
SCD3 0.019 0.03
14.Secondary Outcome
Title Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1
Hide Description SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.
Time Frame From Month 2.5 to Month 14
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2830 3995 1466 2008
Measure Type: Number
Unit of Measure: Percentage of subjects
SPFMI PCD 2.0 1.5 3.8 2.3
SPFMI SCD1 2.6 1.6 4.9 2.5
15.Secondary Outcome
Title Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1
Hide Description SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.
Time Frame From Month 2.5 to Month 20 at Booster
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Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 4557 3996 2328 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
SPFMI PCD 0.03 0.03 0.04 0.03
SPFMI SCD1 0.03 0.03 0.05 0.03
16.Secondary Outcome
Title Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1
Hide Description SPFMI of PCD = PFMI >5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL.
Time Frame From Month 2.5, from Month 20(booster), from Month 33 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17M age category and of 38 months post-Dose 1 for 6-12W age category) and from Month 2.5 to Month 32 and from Month 20 to Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
PCD, M2.5 to SE Number Analyzed 2276 participants 2306 participants 2336 participants 1985 participants 2005 participants 2007 participants
0.04 0.06 0.06 0.04 0.04 0.05
PCD, M20 to SE Number Analyzed 2017 participants 2057 participants 2051 participants 1743 participants 1788 participants 1762 participants
0.03 0.04 0.02 0.02 0.03 0.03
PCD, M33 to SE Number Analyzed 1784 participants 1838 participants 1864 participants 1516 participants 1548 participants 1546 participants
0.01 0.02 0.01 0.01 0.01 0.01
PCD, M2.5 to M32 Number Analyzed 2276 participants 2306 participants 2336 participants 1985 participants 2005 participants 2007 participants
0.03 0.05 0.05 0.04 0.04 0.04
PCD, M20 to M32 Number Analyzed 2017 participants 2057 participants 2051 participants 1743 participants 1788 participants 1762 participants
0.02 0.02 0.02 0.01 0.02 0.02
SCD1, M2.5 to SE Number Analyzed 2276 participants 2306 participants 2336 participants 1985 participants 2005 participants 2007 participants
0.05 0.07 0.07 0.04 0.05 0.06
SCD1, M20 to SE Number Analyzed 2017 participants 2057 participants 2051 participants 1743 participants 1788 participants 1762 participants
0.03 0.04 0.03 0.02 0.03 0.03
SCD1, M33 to SE Number Analyzed 1784 participants 1838 participants 1864 participants 1516 participants 1548 participants 1546 participants
0.01 0.02 0.01 0.01 0.01 0.01
SCD1, M2.5 to M32 Number Analyzed 2276 participants 2306 participants 2336 participants 1985 participants 2005 participants 2007 participants
0.04 0.06 0.06 0.04 0.04 0.05
SCD1, M20 to M32 Number Analyzed 2017 participants 2057 participants 2051 participants 1743 participants 1788 participants 1762 participants
0.02 0.03 0.02 0.01 0.02 0.02
17.Secondary Outcome
Title Percentage of Subjects With Incident Severe Anaemia (ISA) and Malaria Hospitalization (MH) for Case Definitions (CD) Considered
Hide Description CD considered were CD1 for ISA and CD1 and CD2 for MH. ISA of CD1 was defined as a documented hemoglobin < 5.0 g/dL identified at clinical presentation to morbidity surveillance system in association with a P. falciparum parasitemia > 5000 parasites/μL. MH of CD1 was defined as a medical hospitalization with confirmed P. falciparum > 5000 parasites/μL. MH of CD2 was defined as a hospitalization which, in the judgment of the principal investigator, P. falciparum infection was the sole or a major contributing factor to the presentation. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
Time Frame From Month 2.5 to Month 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 4557 3996 2328 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
ISA CD1 0.01 0.01 0.01 0.01
MH CD1 0.05 0.04 0.09 0.05
MH CD2 0.06 0.05 0.1 0.06
18.Secondary Outcome
Title Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered
Hide Description ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.
Time Frame From Month 2.5 to up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
ISA CD1 0.01 0.01 0.02 0.01 0.01 0.02
ISA CD2 0.01 0.02 0.02 0.01 0.02 0.02
ISA CD3 0.02 0.02 0.02 0.02 0.03 0.03
MH CD1 0.07 0.1 0.12 0.06 0.07 0.08
MH CD2 0.09 0.11 0.13 0.08 0.09 0.1
FM PCD 0 0 0 0 0 0
FM SCD1 0 0 0 0 0 0
FM SCD4 0 0 0 0 0.01 0
19.Secondary Outcome
Title Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered
Hide Description ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.
Time Frame From Month 2.5 to Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
ISA CD1 0.01 0.01 0.01 0.1 0.01 0.01
ISA CD2 0.01 0.01 0.02 0.01 0.01 0.01
ISA CD3 0.01 0.02 0.02 0.02 0.02 0.02
MH CD1 0.06 0.09 0.11 0.05 0.06 0.07
MH CD2 0.08 0.1 0.12 0.07 0.08 0.09
FM PCD 0 0 0 0 0 0
FM SCD1 0 0 0 0 0 0
FM SCD4 0 0 0 0 0 0
20.Secondary Outcome
Title Percentage of Subjects With Prevalent Parasitemia, Prevalent Gametocytemia and Prevalent Severe and Moderate Anemia
Hide Description Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent gametocytemia (PG) was defined as a documented P. falciparum gametocyte density > 0 identified at a cross sectional survey. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at at timing of assessment. Results presented are uncorrected for the double enrollment of one subject receiving RTS,S/AS01.
Time Frame At Month 20 (Booster)
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Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 6-12W groups for the PG category.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 4140 3571 2100 1766
Measure Type: Number
Unit of Measure: Percentage of subjects
PP Number Analyzed 4140 participants 3571 participants 2100 participants 1766 participants
0.07 0.07 0.11 0.08
PSA Number Analyzed 4139 participants 3571 participants 2097 participants 1765 participants
0 0 0 0
PMA Number Analyzed 4139 participants 3571 participants 2097 participants 1765 participants
0.03 0.04 0.03 0.04
PG Number Analyzed 4021 participants 0 participants 2025 participants 0 participants
0.03 0.04
21.Secondary Outcome
Title Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia
Hide Description Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at timing of assessment. Analysis was performed on subjects aged 5-17 months at enrollment. Study End (Early) corresponds to children whose Month 32 visit took place after 30 June 2012 and who had one cross-sectional visit at study end. These children’s last study visit was relatively earlier, with a median follow-up time of 14 months post Month 32. Study End (Late) corresponds to children whose Month 32 visit took place before (and including) 30 June 2012, and who had 2 cross-sectional visits after Month 32. These children’s last study visit was relatively later, with a median follow-up time of 17 months post Month 32).
Time Frame At Months 32, 44, at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category) (early and late)
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Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period 14 days post Dose 3. Data was not collected for the participants in the 6-12W groups for the PP, PSA, PMA categories at M44, SE (Late).
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 1935 1967 1979 1637 1656 1648
Measure Type: Number
Unit of Measure: Percentage of subjects
PP, Month 32 Number Analyzed 1935 participants 1963 participants 1976 participants 1635 participants 1656 participants 1647 participants
0.09 0.1 0.14 0.09 0.11 0.1
PSA, Month 32 Number Analyzed 1934 participants 1967 participants 1979 participants 1637 participants 1655 participants 1648 participants
0 0 0 0 0 0
PMA, Month 32 Number Analyzed 1934 participants 1967 participants 1979 participants 1637 participants 1655 participants 1648 participants
0.02 0.02 0.02 0.02 0.04 0.03
PP, Month 44 Number Analyzed 1039 participants 1072 participants 1093 participants 0 participants 0 participants 0 participants
0.16 0.17 0.2
PSA, Month 44 Number Analyzed 1041 participants 1072 participants 1094 participants 0 participants 0 participants 0 participants
0 0 0
PMA, Month 44 Number Analyzed 1041 participants 1072 participants 1094 participants 0 participants 0 participants 0 participants
0.01 0.02 0.01
PP, SE (Early) Number Analyzed 681 participants 661 participants 672 participants 1481 participants 1472 participants 1487 participants
0.09 0.1 0.14 0.11 0.14 0.13
PSA, SE (Early) Number Analyzed 681 participants 661 participants 672 participants 1481 participants 1472 participants 1486 participants
0 0 0 0 0 0
PMA, SE (Early) Number Analyzed 681 participants 661 participants 672 participants 1481 participants 1472 participants 1486 participants
0.01 0.02 0.03 0.03 0.03 0.03
PP, SE (Late) Number Analyzed 1054 participants 1059 participants 1104 participants 0 participants 0 participants 0 participants
0.18 0.18 0.21
PSA, SE (Late) Number Analyzed 1053 participants 1057 participants 1104 participants 0 participants 0 participants 0 participants
0 0 0
PMA, SE (Late) Number Analyzed 1053 participants 1057 participants 1104 participants 0 participants 0 participants 0 participants
0.03 0.03 0.02
22.Secondary Outcome
Title Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed
Hide Description Pneumonia case definitions assessed are PCD and SCD 1, 2 and 3. Pneumonia of PCD was defined as cough or difficulty breathing AND tachypnea (≥ 50 breaths per minute < 1 year, ≥ 40 breaths per minute ≥ 1year) AND lower chest wall indrawing. Pneumonia of SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission. Pneumonia of SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission. Pneumonia of SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation < 90%. All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excludes planned admissions for medical investigation/care or elective surgery and trauma). Sepsis cases were defined as a child with positive blood culture (CD1) or salmonella blood culture (CD2).
Time Frame From Month 2.5 to Month 20
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Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 4557 3996 2328 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
Pneumonia PCD 0.03 0.04 0.03 0.04
Pneumonia SCD1 0.01 0.01 0 0.01
Pneumonia SCD2 0.02 0.03 0.02 0.03
Pneumonia SCD3 0 0.01 0.01 0.01
All-Cause Hospitalization PCD 0.15 0.18 0.19 0.19
Sepsis CD1 0.02 0.02 0.02 0.01
Sepsis CD2 0.01 0.01 0.01 0.01
23.Secondary Outcome
Title Percentage of Subjects With Fatal Malaria (FM) and All-cause Mortality (ACM) as Per Case Definitions Assessed
Hide Description Fatal malaria case definitions assessed were PCD and SCD1. Fatal malaria of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease (defined in a previous outcome measure) with a fatal outcome. Fatal malaria of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease (defined previously) with a fatal outcome. All-cause mortality case definitions assessed were the case definitions (CD) 1 and 2. All-cause mortality of CD1 was defined as a fatality (of any cause) (including mortality in the community and in hospital). All-cause mortality of CD2 was defined as a fatality (medical cause) (including mortality in the community and in hospital), at the exclusion of trauma which may be diagnosed by verbal autopsy. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
Time Frame From Month 2.5 to Month 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 4557 3996 2328 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
Fatal Malaria PCD 0 0 0 0
Fatal Malaria SCD1 0 0 0 0
All-cause mortality CD1 0.01 0.01 0.01 0.01
All-cause mortality CD2 0.01 0.01 0.01 0.01
24.Secondary Outcome
Title Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed
Hide Description Pneumonia of PCD was defined as cough or difficulty breathing (on history) AND tachypnea (>= 50 breaths per minute < 1 year, >= 40 breaths per minute >= 1year) AND lower chest wall indrawing,SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission,SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission,SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation less than 90%.All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excluding planned admissions for medical investigation/care or elective surgery and trauma).All-cause mortality of CD1 was defined as a fatality (of any cause),of CD2 defined as a fatality (medical cause).Sepsis of CD1 was defined as a child with positive blood culture;CD2 defined as a child with positive salmonella blood culture.
Time Frame From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
All-Cause Hospitalization PCD 0.21 0.22 0.24 0.23 0.23 0.24
Sepsis CD1 0.02 0.02 0.03 0.02 0.02 0.02
Sepsis CD2 0.01 0.01 0.02 0.01 0.02 0.01
Pneumonia PCD 0.04 0.03 0.03 0.05 0.05 0.05
Pneumonia SCD1 0.01 0.01 0.01 0.01 0.01 0.01
Pneumonia SCD2 0.03 0.02 0.02 0.03 0.03 0.03
Pneumonia SCD3 0 0 0.01 0.01 0.01 0.01
All-Cause Mortality CD1 0.01 0.01 0.01 0.02 0.02 0.01
All-Cause Mortality CD2 0.01 0.01 0.01 0.02 0.02 0.01
25.Secondary Outcome
Title Percentage of Subjects With Blood Transfusion, as Per Case Definition Assessed
Hide Description Blood transfusion case definition assessed was the case definition 1 (CD1). Blood transfusion of CD1 was defined as a child with inpatient admission with documented blood transfusion.
Time Frame From Month 2.5 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: Percentage of subjects
0.03 0.03 0.04 0.03 0.03 0.04
26.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Gender and Overall
Hide Description CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). Analysis was performed on subjects aged 5-17 months and 6-12 weeks at enrollment. Results were presented by gender and overall.
Time Frame From Month 2.5 to Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2276 2306 2336 1985 2005 2007
Measure Type: Number
Unit of Measure: events per person-year
PCD Females Number Analyzed 1123 participants 1137 participants 1167 participants 967 participants 976 participants 1014 participants
0.72 0.8 1.11 0.76 0.79 1.06
PCD Males Number Analyzed 1153 participants 1169 participants 1169 participants 1018 participants 1029 participants 993 participants
0.65 0.81 1.19 0.83 0.96 1.01
PCD Overall Number Analyzed 2276 participants 2306 participants 2336 participants 1985 participants 2005 participants 2007 participants
0.68 0.81 1.15 0.8 0.88 1.03
27.Secondary Outcome
Title Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ)
Hide Description Anthropometry consisted of length/height for age z-score [HAZ] (children < 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score [WAZ] and mid-upper arm circumference for age z-score [MUACZ] measurements, where a HAZ < -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ > -3 and ≤ -2 z-score indicates a low weight for age, a WAZ > - 2 z-score indicates normal weight. A MUACZ < -2 z-score indicates children that are wasted, a MUACZ < - 3 z-score indicates severely wasted children.
Time Frame At Month 20 (Booster)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Intent-to-Treat (ITT) population, which included all children who received at least one dose of study vaccine.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 5948 4358 2974 2179
Mean (Standard Deviation)
Unit of Measure: z-score
HAZ Number Analyzed 5048 participants 4358 participants 2974 participants 2179 participants
-1.6  (1) -1.7  (1.1) -1.6  (1) -1.7  (1.2)
WAZ Number Analyzed 5948 participants 4358 participants 2974 participants 2179 participants
-1  (1) -0.9  (1) -1  (1) -0.9  (1)
MUACZ Number Analyzed 5948 participants 4358 participants 2974 participants 2179 participants
-0.3  (0.9) -0.1  (1) -0.3  (0.9) -0.1  (1)
28.Secondary Outcome
Title Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ)
Hide Description Anthropometry consisted of length/height for age z-score [HAZ] (children < 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score [WAZ] and mid-upper arm circumference for age z-score [MUACZ] measurements, where a HAZ < -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ > -3 and ≤ -2 z-score indicates a low weight for age, a WAZ > - 2 z-score indicates normal weight. A MUACZ < -2 z-score indicates children that are wasted, a MUACZ < - 3 z-score indicates severely wasted children. Note: The early study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end and to late study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end.
Time Frame At Months 32, 44, at study end (early and late) (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine. Data was not collected for the participants in the 6-12W groups for the HAZ, WAZ, MUACZ categories at Month 44 and at Study end Late time frames.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 2363 2382 2392 1726 1731 1725
Mean (Standard Deviation)
Unit of Measure: z-score
HAZ, Month 32 Number Analyzed 2363 participants 2382 participants 2392 participants 1726 participants 1731 participants 1725 participants
-1.3  (1.0) -1.4  (1.0) -1.4  (1.0) -1.5  (1.1) -1.4  (1.1) -1.5  (1.1)
WAZ, Month 32 Number Analyzed 2363 participants 2382 participants 2392 participants 1726 participants 1731 participants 1725 participants
-0.9  (0.9) -1.0  (0.9) -1.0  (0.9) -0.9  (1.0) -0.9  (1.0) -0.9  (1.0)
MUACZ, Month 32 Number Analyzed 2363 participants 2382 participants 2392 participants 1726 participants 1731 participants 1725 participants
-0.4  (0.9) -0.4  (0.9) -0.4  (0.8) -0.4  (0.9) -0.3  (1.0) -0.4  (1.0)
HAZ, Month 44 Number Analyzed 1275 participants 1289 participants 1307 participants 0 participants 0 participants 0 participants
-1.1  (1.0) -1.2  (0.9) -1.2  (1.0)
WAZ, Month 44 Number Analyzed 1275 participants 1289 participants 1307 participants 0 participants 0 participants 0 participants
-0.9  (0.9) -1.0  (0.9) -0.9  (0.8)
MUACZ, Month 44 Number Analyzed 1275 participants 1289 participants 1307 participants 0 participants 0 participants 0 participants
-0.7  (0.8) -0.7  (0.9) -0.6  (0.8)
HAZ, Study end Early Number Analyzed 774 participants 755 participants 768 participants 1555 participants 1533 participants 1549 participants
-1.3  (1.0) -1.3  (1.0) -1.3  (1.0) -1.4  (1.0) -1.4  (1.0) -1.4  (1.0)
WAZ, Study end Early Number Analyzed 774 participants 755 participants 768 participants 1555 participants 1533 participants 1549 participants
-1.0  (0.8) -1.0  (0.8) -1.0  (0.8) -0.9  (0.9) -0.9  (0.9) -0.9  (0.9)
MUACZ, Study end Early Number Analyzed 774 participants 755 participants 768 participants 1555 participants 1533 participants 1549 participants
-0.8  (0.9) -0.8  (0.9) -0.8  (0.8) -0.5  (0.9) -0.4  (0.9) -0.5  (0.9)
HAZ, Study end Late Number Analyzed 1290 participants 1283 participants 1317 participants 0 participants 0 participants 0 participants
-1.0  (0.9) -1.1  (0.9) -1.1  (1.0)
WAZ, Study end Late Number Analyzed 1290 participants 1283 participants 1317 participants 0 participants 0 participants 0 participants
-0.9  (0.9) -1.0  (0.9) -1.0  (0.8)
MUACZ, Study end Late Number Analyzed 1290 participants 1283 participants 1317 participants 0 participants 0 participants 0 participants
-0.7  (0.8) -0.8  (0.9) -0.7  (0.8)
29.Secondary Outcome
Title Antibody Concentrations Against Plasmodium Falciparum Circumsporozoite (Anti-CS)
Hide Description Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 subjects enrolled in each study center.
Time Frame At Day 0 and at Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center in each age category who received all vaccinations according to the protocol procedures.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 1036 1234 529 627
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Day 0 Number Analyzed 1036 participants 1234 participants 526 participants 627 participants
0.3
(0.3 to 0.3)
0.4
(0.4 to 0.4)
0.3
(0.3 to 0.3)
0.4
(0.4 to 0.5)
Anti-CS, Month 3 Number Analyzed 1034 participants 1221 participants 529 participants 627 participants
621
(591.5 to 651.9)
210.5
(198.2 to 223.6)
0.3
(0.3 to 0.3)
0.3
(0.3 to 0.3)
30.Secondary Outcome
Title Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)
Hide Description Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.
Time Frame At Day 0 and at Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the HIV-ATP population for immunogenicity, which included all children included in the HIV-ITT population who received all vaccinations according to the protocol procedures.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 29 25 17 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Day 0 Number Analyzed 28 participants 25 participants 16 participants 5 participants
0.3
(0.2 to 0.5)
0.3
(0.2 to 0.4)
0.4
(0.3 to 0.5)
0.3
(0.3 to 0.3)
Anti-CS, Month 3 Number Analyzed 29 participants 24 participants 17 participants 5 participants
264.7
(137.5 to 509.6)
125.3
(58.1 to 270.3)
0.5
(0.2 to 1.7)
0.3
(0.3 to 0.3)
31.Secondary Outcome
Title Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)
Hide Description Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL.
Time Frame At Months 20, 21 and 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center in each age category who received all vaccinations according to the protocol procedures. Data was not collected for the participants in the 5-17M groups for the Manhica site at any given time frame.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 442 438 426 530 569 554
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Agogo - Month 20 Number Analyzed 55 participants 57 participants 54 participants 55 participants 55 participants 66 participants
34.1
(24.0 to 48.3)
52.1
(41.3 to 65.7)
0.3
(0.3 to 0.4)
5.1
(3.4 to 7.6)
5.6
(3.8 to 8.4)
0.3
(0.2 to 0.3)
Anti-CS, Agogo - Month 21 Number Analyzed 51 participants 53 participants 53 participants 55 participants 55 participants 65 participants
265.0
(220.9 to 317.9)
48.3
(37.6 to 61.9)
0.3
(0.2 to 0.3)
137.6
(95.0 to 199.3)
5.3
(3.5 to 8.0)
0.3
(0.2 to 0.3)
Anti-CS, Agogo - Month 32 Number Analyzed 53 participants 54 participants 54 participants 52 participants 53 participants 64 participants
46.3
(34.8 to 61.6)
28.8
(21.8 to 37.9)
0.3
(0.2 to 0.3)
14.8
(9.5 to 23.1)
2.9
(1.9 to 4.5)
0.3
(0.3 to 0.4)
Anti-CS, Bagamoyo - Month 20 Number Analyzed 16 participants 18 participants 25 participants 47 participants 54 participants 42 participants
26.6
(14.2 to 49.9)
23.1
(11.1 to 47.8)
0.3
(0.3 to 0.3)
6.9
(4.8 to 10.0)
7.6
(5.1 to 11.4)
0.3
(0.2 to 0.3)
Anti-CS, Bagamoyo - Month 21 Number Analyzed 16 participants 18 participants 24 participants 46 participants 53 participants 42 participants
306.6
(206.5 to 455.4)
31.8
(19.4 to 52.2)
0.6
(0.2 to 1.4)
169.9
(129.8 to 222.5)
7.2
(4.5 to 11.6)
0.3
(0.2 to 0.4)
Anti-CS, Bagamoyo - Month 32 Number Analyzed 16 participants 17 participants 24 participants 43 participants 49 participants 40 participants
44.6
(27.2 to 73.3)
16.9
(10.2 to 27.9)
0.3
(0.3 to 0.3)
14.4
(9.6 to 21.7)
3.7
(2.4 to 5.7)
0.3
(0.3 to 0.3)
Anti-CS, Kilifi - Month 20 Number Analyzed 43 participants 50 participants 42 participants 43 participants 56 participants 53 participants
34.3
(26.3 to 44.7)
33.1
(26.3 to 41.6)
0.3
(0.3 to 0.3)
6.6
(4.6 to 9.6)
6.1
(4.0 to 9.4)
0.3
(0.2 to 0.3)
Anti-CS, Kilifi - Month 21 Number Analyzed 40 participants 49 participants 41 participants 41 participants 54 participants 51 participants
308.4
(251.8 to 377.7)
24.3
(18.1 to 32.8)
0.3
(0.3 to 0.3)
229.3
(175.4 to 299.9)
5.3
(3.4 to 8.2)
0.3
(0.3 to 0.3)
Anti-CS, Kilifi - Month 32 Number Analyzed 42 participants 47 participants 39 participants 42 participants 51 participants 50 participants
59.4
(45.7 to 77.2)
14.9
(11.0 to 20.2)
0.3
(0.2 to 0.4)
19.8
(14.1 to 27.8)
2.8
(1.8 to 4.4)
0.3
(0.3 to 0.3)
Anti-CS, Kintampo - Month 20 Number Analyzed 57 participants 51 participants 52 participants 52 participants 55 participants 46 participants
50.8
(37.2 to 69.5)
36.6
(26.4 to 50.7)
0.4
(0.3 to 0.5)
3.8
(2.5 to 5.8)
3.7
(2.5 to 5.6)
0.3
(0.3 to 0.4)
Anti-CS, Kintampo - Month 21 Number Analyzed 54 participants 47 participants 47 participants 47 participants 50 participants 43 participants
266.8
(188.9 to 377.0)
41.2
(31.2 to 54.6)
0.3
(0.2 to 0.3)
128.8
(95.7 to 173.4)
3.2
(2.0 to 5.0)
0.3
(0.3 to 0.4)
Anti-CS, Kintampo - Month 32 Number Analyzed 50 participants 46 participants 49 participants 47 participants 47 participants 42 participants
70.9
(55.2 to 90.9)
20.2
(14.3 to 28.5)
0.4
(0.3 to 0.5)
13.3
(8.1 to 21.9)
2.2
(1.4 to 3.4)
0.3
(0.3 to 0.3)
Anti-CS, Kombewa - Month 20 Number Analyzed 54 participants 50 participants 60 participants 54 participants 54 participants 54 participants
39.8
(29.9 to 53.0)
46.6
(33.2 to 65.3)
0.3
(0.3 to 0.4)
5.5
(3.6 to 8.4)
8.7
(5.8 to 13.0)
0.4
(0.3 to 0.5)
Anti-CS, Kombewa - Month 21 Number Analyzed 52 participants 50 participants 59 participants 50 participants 51 participants 52 participants
308.5
(252.4 to 377.0)
37.1
(26.7 to 51.5)
0.4
(0.3 to 0.4)
146.3
(96.6 to 221.6)
9.2
(6.0 to 14.2)
0.4
(0.3 to 0.5)
Anti-CS, Kombewa - Month 32 Number Analyzed 48 participants 46 participants 56 participants 46 participants 48 participants 51 participants
53.8
(40.3 to 71.7)
19.8
(14.1 to 27.7)
0.3
(0.3 to 0.4)
8.3
(4.8 to 14.3)
4.3
(2.8 to 6.6)
0.4
(0.3 to 0.4)
Anti-CS, Korogwe - Month 20 Number Analyzed 55 participants 61 participants 52 participants 52 participants 48 participants 57 participants
29.4
(21.4 to 40.4)
28.2
(22.5 to 35.3)
0.3
(0.3 to 0.3)
7.9
(5.3 to 11.8)
8.1
(5.2 to 12.7)
0.3
(0.2 to 0.3)
Anti-CS, Korogwe - Month 21 Number Analyzed 50 participants 61 participants 48 participants 50 participants 46 participants 54 participants
305.6
(266.4 to 350.5)
27.1
(20.7 to 35.5)
0.3
(0.2 to 0.3)
178.3
(141.2 to 225.1)
7.6
(4.8 to 11.9)
0.3
(0.2 to 0.4)
Anti-CS, Korogwe - Month 32 Number Analyzed 52 participants 56 participants 44 participants 49 participants 42 participants 48 participants
47.4
(37.5 to 59.9)
16.8
(13.1 to 21.7)
0.3
(0.2 to 0.3)
19.6
(13.0 to 29.6)
4.9
(3.0 to 7.9)
0.3
(0.2 to 0.3)
Anti-CS, Lambarene - Month 20 Number Analyzed 32 participants 30 participants 29 participants 44 participants 46 participants 39 participants
8.2
(5.8 to 11.6)
11.1
(7.0 to 17.6)
0.3
(0.2 to 0.3)
7.7
(5.1 to 11.6)
8.3
(5.8 to 12.1)
0.3
(0.3 to 0.3)
Anti-CS, Lambarene - Month 21 Number Analyzed 32 participants 30 participants 29 participants 43 participants 45 participants 35 participants
203.6
(155.1 to 267.3)
10.6
(6.6 to 16.8)
0.3
(0.2 to 0.3)
251.3
(184.8 to 341.7)
7.4
(5.0 to 10.8)
0.3
(0.2 to 0.3)
Anti-CS, Lambarene - Month 32 Number Analyzed 29 participants 29 participants 27 participants 38 participants 43 participants 33 participants
23.0
(15.6 to 33.9)
5.9
(3.6 to 9.9)
0.3
(0.2 to 0.4)
21.0
(13.9 to 31.7)
4.1
(2.9 to 5.8)
0.3
(0.2 to 0.3)
Anti-CS, Lilongwe - Month 20 Number Analyzed 21 participants 17 participants 25 participants 48 participants 46 participants 53 participants
45.9
(28.6 to 73.8)
22.2
(11.2 to 44.0)
0.4
(0.2 to 0.7)
5.1
(3.2 to 8.3)
7.4
(4.7 to 11.5)
0.3
(0.3 to 0.4)
Anti-CS, Lilongwe - Month 21 Number Analyzed 23 participants 15 participants 24 participants 44 participants 45 participants 51 participants
285.0
(228.5 to 355.4)
17.0
(8.1 to 35.7)
0.3
(0.2 to 0.4)
126.1
(92.7 to 171.5)
8.0
(5.2 to 12.1)
0.3
(0.2 to 0.4)
Anti-CS, Lilongwe - Month 32 Number Analyzed 19 participants 16 participants 22 participants 45 participants 46 participants 50 participants
45.6
(28.8 to 72.3)
12.7
(6.4 to 25.3)
0.3
(0.2 to 0.4)
15.4
(9.3 to 25.4)
4.5
(3.1 to 6.6)
0.3
(0.2 to 0.3)
Anti-CS, Nanoro - Month 20 Number Analyzed 63 participants 60 participants 56 participants 50 participants 69 participants 53 participants
57.2
(43.4 to 75.4)
61.8
(46.3 to 82.4)
0.3
(0.3 to 0.3)
2.7
(1.7 to 4.4)
3.2
(2.1 to 4.7)
0.3
(0.3 to 0.4)
Anti-CS, Nanoro - Month 21 Number Analyzed 63 participants 60 participants 56 participants 50 participants 68 participants 53 participants
520.5
(443.4 to 611.1)
71.1
(54.8 to 92.3)
0.3
(0.2 to 0.3)
163.2
(121.4 to 219.4)
3.1
(2.0 to 4.6)
0.3
(0.3 to 0.4)
Anti-CS, Nanoro - Month 32 Number Analyzed 60 participants 57 participants 51 participants 45 participants 66 participants 51 participants
69.2
(55.2 to 86.9)
35.0
(25.7 to 47.9)
0.3
(0.3 to 0.3)
11.9
(7.4 to 19.2)
2.8
(2.0 to 4.0)
0.5
(0.4 to 0.6)
Anti-CS, Siaya - Month 20 Number Analyzed 46 participants 44 participants 31 participants 40 participants 40 participants 48 participants
28.4
(18.4 to 44.0)
32.8
(21.6 to 50.1)
0.3
(0.3 to 0.4)
7.0
(4.2 to 11.5)
8.9
(5.5 to 14.2)
0.4
(0.3 to 0.5)
Anti-CS, Siaya - Month 21 Number Analyzed 45 participants 42 participants 28 participants 41 participants 39 participants 45 participants
398.1
(324.6 to 488.2)
36.4
(22.6 to 58.6)
0.3
(0.2 to 0.4)
171.5
(109.8 to 267.9)
8.4
(5.2 to 13.6)
0.4
(0.3 to 0.5)
Anti-CS, Siaya - Month 32 Number Analyzed 45 participants 40 participants 27 participants 36 participants 36 participants 42 participants
55.8
(41.4 to 75.3)
21.7
(13.4 to 35.1)
0.4
(0.3 to 0.5)
23.6
(14.2 to 39.1)
5.5
(3.3 to 9.2)
0.5
(0.4 to 0.7)
Anti-CS, Manhica - Month 20 Number Analyzed 0 participants 0 participants 0 participants 45 participants 46 participants 43 participants
12.3
(8.4 to 18.1)
14.7
(10.0 to 21.5)
0.3
(0.3 to 0.3)
Anti-CS, Manhica - Month 21 Number Analyzed 0 participants 0 participants 0 participants 36 participants 38 participants 28 participants
260.2
(176.4 to 383.8)
12.3
(7.7 to 19.5)
0.3
(0.2 to 0.3)
Anti-CS, Manhica - Month 32 Number Analyzed 0 participants 0 participants 0 participants 35 participants 34 participants 30 participants
25.4
(14.8 to 43.5)
6.8
(4.0 to 11.5)
0.3
(0.3 to 0.3)
Anti-CS, Overall sites - Month 20 Number Analyzed 442 participants 438 participants 426 participants 530 participants 569 participants 554 participants
34.4
(30.7 to 38.6)
35.4
(31.7 to 39.5)
0.3
(0.3 to 0.3)
5.9
(5.2 to 6.7)
6.6
(5.8 to 7.5)
0.3
(0.3 to 0.3)
Anti-CS, Overall sites - Month 21 Number Analyzed 426 participants 425 participants 409 participants 503 participants 544 participants 519 participants
318.2
(295.1 to 343.0)
34.2
(30.5 to 38.3)
0.3
(0.3 to 0.3)
169.9
(153.8 to 187.7)
6.2
(5.4 to 7.0)
0.3
(0.3 to 0.3)
Anti-CS, Overall sites - Month 32 Number Analyzed 414 participants 408 participants 393 participants 478 participants 515 participants 501 participants
52.4
(47.8 to 57.6)
19.3
(17.2 to 21.8)
0.3
(0.3 to 0.3)
15.9
(13.8 to 18.3)
3.7
(3.3 to 4.2)
0.3
(0.3 to 0.3)
32.Secondary Outcome
Title Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)
Hide Description Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results for this endpoint were assessed for Agogo, Lilongwe and Siaya sites.
Time Frame At Month 44 and at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center in each age category who received all vaccinations according to the protocol procedures. Data was not collected for the participants in the 6-12W groups at M44.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 104 101 98 101 103 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Agogo - Month 44 Number Analyzed 47 participants 50 participants 45 participants 0 participants 0 participants 0 participants
27.7
(20.1 to 38.1)
17.9
(13.5 to 23.6)
0.3
(0.2 to 0.3)
Anti-CS, Agogo - Study end Number Analyzed 47 participants 48 participants 49 participants 32 participants 35 participants 51 participants
23.2
(16.7 to 32.3)
17.2
(12.7 to 23.3)
0.3
(0.2 to 0.3)
6.1
(3.2 to 11.4)
2.1
(1.3 to 3.4)
0.3
(0.2 to 0.4)
Anti-CS, Lilongwe - Month 44 Number Analyzed 15 participants 16 participants 19 participants 0 participants 0 participants 0 participants
30.5
(21.4 to 43.5)
8.5
(4.5 to 15.9)
0.3
(0.2 to 0.3)
Anti-CS, Lilongwe - Study end Number Analyzed 16 participants 17 participants 23 participants 35 participants 38 participants 42 participants
26.9
(18.3 to 39.5)
7.2
(4.1 to 12.5)
0.3
(0.3 to 0.3)
10.9
(6.3 to 18.7)
2.8
(1.8 to 4.2)
0.3
(0.2 to 0.3)
Anti-CS, Siaya - Month 44 Number Analyzed 41 participants 35 participants 22 participants 0 participants 0 participants 0 participants
41.4
(29.7 to 57.9)
21.2
(14.0 to 32.0)
0.5
(0.4 to 0.8)
Anti-CS, Siaya - Study end Number Analyzed 41 participants 34 participants 26 participants 34 participants 30 participants 38 participants
27.4
(19.4 to 38.9)
15.8
(10.2 to 24.4)
0.4
(0.3 to 0.6)
10.4
(6.1 to 17.7)
3.3
(1.9 to 5.6)
0.4
(0.3 to 0.6)
Anti-CS, Overall - Month 44 Number Analyzed 103 participants 101 participants 86 participants 0 participants 0 participants 0 participants
33.0
(26.9 to 40.3)
16.8
(13.5 to 21.0)
0.3
(0.3 to 0.4)
Anti-CS, Overall - Study end Number Analyzed 104 participants 99 participants 98 participants 101 participants 103 participants 131 participants
25.4
(20.6 to 31.2)
14.4
(11.4 to 18.1)
0.3
(0.3 to 0.4)
8.9
(6.5 to 12.3)
2.6
(2.0 to 3.4)
0.3
(0.3 to 0.4)
33.Secondary Outcome
Title Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile
Hide Description Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.
Time Frame At Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - Menjugate [5-17M] Group GSK257049 - Menjugate [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 545 639
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Tertile 1 Number Analyzed 181 participants 212 participants
264.15
(238.2 to 292.9)
78.45
(69.4 to 88.6)
Anti-CS, Tertile 2 Number Analyzed 182 participants 214 participants
613.79
(598.3 to 629.7)
230.68
(224.7 to 236.8)
Anti-CS, Tertile 3 Number Analyzed 182 participants 213 participants
1351.41
(1276.3 to 1431)
592.65
(557.8 to 629.6)
Anti-CS, Across Tertiles Number Analyzed 545 participants 639 participants
603.77
(563.6 to 646.8)
220.9
(204.1 to 239)
34.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile
Hide Description CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post primary vaccination pooled across sites, on subjects in GSK257049-Menjugate Groups (5-17M; 6-12W) and Comparator Groups (5-17M; 6-12W), taking into account the first 200 participants per site.
Time Frame From Month 2.5 to Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - Menjugate [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 - Menjugate [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 182 565 214 677
Measure Type: Number
Unit of Measure: events per person-year
Tertile 1 Number Analyzed 181 participants 565 participants 212 participants 677 participants
0.68 1.21 1.29 0.93
Tertile 2 Number Analyzed 182 participants 565 participants 214 participants 677 participants
0.78 1.21 0.7 0.93
Tertile 3 Number Analyzed 182 participants 565 participants 213 participants 677 participants
1.03 1.21 0.58 0.93
35.Secondary Outcome
Title Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile
Hide Description Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.
Time Frame At Month 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 -GSK257049 [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 465 546
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Tertile 1 Number Analyzed 154 participants 181 participants
138.15
(123.5 to 154.5)
47.99
(41.2 to 55.9)
Anti-CS, Tertile 2 Number Analyzed 156 participants 183 participants
311.35
(303.4 to 319.6)
194.85
(189.9 to 200)
Anti-CS, Tertile 3 Number Analyzed 155 participants 182 participants
675.24
(632.8 to 720.5)
479.44
(446.8 to 514.5)
Anti-CS, Across Tertiles Number Analyzed 465 participants 546 participants
307.93
(286.2 to 331.3)
165.31
(150 to 182.2)
36.Secondary Outcome
Title Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile
Hide Description CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post booster vaccination pooled across sites, on subjects in R3R (5-17M; 6-12W) (or R3R below) and C3C (5-17M; 6-12W) (or C3C below) groups taking into account the first 200 participants per site.
Time Frame From Booster at Month 20 to Month 32
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 -GSK257049 [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 156 479 420 594
Measure Type: Number
Unit of Measure: events per person-year
Tertile 1 Number Analyzed 154 participants 479 participants 420 participants 594 participants
0.68 1.21 0.99 0.94
Tertile 2 Number Analyzed 156 participants 479 participants 362 participants 594 participants
0.68 1.21 0.84 0.94
Tertile 3 Number Analyzed 155 participants 479 participants 276 participants 594 participants
0.77 1.21 0.64 0.94
37.Secondary Outcome
Title Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)
Hide Description Antibody concentrations assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.
Time Frame At Day 0 and at Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center, for each age category who received all vaccinations according to the protocol procedures.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 1029 1213 526 627
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HBs, Day 0 Number Analyzed 1017 participants 1120 participants 515 participants 561 participants
166.3
(148 to 186.8)
8.6
(8 to 9.3)
168.6
(142.8 to 199.2)
8.5
(7.7 to 9.4)
Anti-HBs, Month 3 Number Analyzed 1029 participants 1213 participants 526 participants 627 participants
81567.7
(75442.7 to 88189.9)
13674.3
(12811.5 to 14595.3)
127.5
(108.8 to 149.4)
728.8
(643.6 to 825.2)
38.Secondary Outcome
Title Antibody Concentrations Against Hepatitis B Surface Antigen
Hide Description Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.
Time Frame At Day 0 and at Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the HIV-ATP population for immunogenicity, which included all children included in the HIV-ITT population who received all vaccinations according to the protocol procedures.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 29 25 17 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HBs, Day 0 Number Analyzed 28 participants 25 participants 15 participants 5 participants
98.6
(43.8 to 222)
7.5
(4.8 to 11.6)
63.6
(19.4 to 208.4)
5
(5 to 5)
Anti-HBs, Month 3 Number Analyzed 29 participants 24 participants 17 participants 5 participants
37476.5
(17766 to 79054.9)
1996.2
(561.6 to 7095.8)
37.1
(9.1 to 151.9)
197.2
(7.7 to 5081.7)
39.Secondary Outcome
Title Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)
Hide Description Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 6.2 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.
Time Frame At Months 20 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP population for HBs immunogenicity post booster, which included the first 200 children enrolled in Korogwe, Lamberene and Lilongwe study centers in each age category who received the booster dose of GSK257049 vaccine and all vaccinations according to the protocol procedures.
Arm/Group Title GSK257049 - GSK257049 [5-17M] Group GSK257049 -GSK257049 [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 95 134
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HBs, Month 20 Number Analyzed 95 participants 134 participants
5068.5
(3711.3 to 6922)
1532.5
(1240.6 to 1893.2)
Anti-HBs, Month 21 Number Analyzed 94 participants 48 participants
95206.4
(72395.4 to 125204.9)
116458.1
(86865.7 to 156131.6)
40.Secondary Outcome
Title Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3
Hide Description Anti-Polio 1, 2 and 3 antibody titers were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was an antibody titer ≥ 1:8.
Time Frame At Day 0 and at Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The ATP population for Polio Sabin™ immunogenicity included all subjects from the ATP population for immunogenicity (minus those who received ≥ 2 doses of Polio Sabin™ vaccine prior to Dose 1 of study vaccine, or who received at least one dose of a polio vaccine in co-administration with the study vaccine before one month post Dose 3 blood sample.
Arm/Group Title GSK257049 [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 931 474
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Anti-Polio 1, Day 0 Number Analyzed 928 participants 469 participants
47.4
(41.7 to 53.8)
43.3
(36.2 to 51.9)
Anti-Polio 1, Month 3 Number Analyzed 913 participants 464 participants
334.9
(295.2 to 379.8)
417.6
(351.4 to 496.2)
Anti-Polio 2, Day 0 Number Analyzed 928 participants 468 participants
38.6
(34.6 to 43.2)
40.3
(34.2 to 47.5)
Anti-Polio 2, Month 3 Number Analyzed 913 participants 466 participants
372.1
(334.5 to 414.0)
450.8
(393.9 to 516.0)
Anti-Polio 3, Day 0 Number Analyzed 931 participants 474 participants
9.4
(8.6 to 10.3)
9.1
(8.0 to 10.3)
Anti-Polio 3, Month 3 Number Analyzed 913 participants 466 participants
80.0
(71.0 to 90.1)
95.9
(82.0 to 112.2)
41.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms included pain, redness and swelling. Any = the incidence of a particular symptom, regardless of intensity grade. Grade 3 pain = cried when limb was moved, spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine and had their symptom sheets filled in.
Arm/Group Title GSK257049 [5-17M] Group VeroRab Comparator [5-17M] Group GSK257049 [6-12W] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 1479 721 1462 738
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
247
  16.7%
61
   8.5%
435
  29.8%
215
  29.1%
Grade 3 Pain, Dose 1 Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
0
   0.0%
0
   0.0%
10
   0.7%
7
   0.9%
Any Redness, Dose 1 Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
66
   4.5%
26
   3.6%
176
  12.0%
89
  12.1%
Grade 3 Redness, Dose 1 Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
2
   0.1%
0
   0.0%
3
   0.2%
3
   0.4%
Any Swelling, Dose 1 Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
140
   9.5%
77
  10.7%
227
  15.5%
125
  16.9%
Grade 3 Swelling, Dose 1 Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
6
   0.4%
0
   0.0%
27
   1.8%
29
   3.9%
Any Pain, Dose 2 Number Analyzed 1435 participants 708 participants 1412 participants 721 participants
179
  12.5%
41
   5.8%
383
  27.1%
178
  24.7%
Grade 3 Pain, Dose 2 Number Analyzed 1435 participants 708 participants 1412 participants 721 participants
3
   0.2%
0
   0.0%
5
   0.4%
3
   0.4%
Any Redness, Dose 2 Number Analyzed 1435 participants 708 participants 1412 participants 721 participants
26
   1.8%
18
   2.5%
124
   8.8%
90
  12.5%
Grade 3 Redness, Dose 2 Number Analyzed 1435 participants 708 participants 1412 participants 721 participants
3
   0.2%
0
   0.0%
3
   0.2%
1
   0.1%
Any Swelling, Dose 2 Number Analyzed 1435 participants 708 participants 1412 participants 721 participants
140
   9.8%
50
   7.1%
228
  16.1%
128
  17.8%
Grade 3 Swelling, Dose 2 Number Analyzed 1435 participants 708 participants 1412 participants 721 participants
15
   1.0%
0
   0.0%
29
   2.1%
17
   2.4%
Any Pain, Dose 3 Number Analyzed 1407 participants 699 participants 1378 participants 710 participants
108
   7.7%
22
   3.1%
345
  25.0%
153
  21.5%
Grade 3 Pain, Dose 3 Number Analyzed 1407 participants 699 participants 1378 participants 710 participants
0
   0.0%
0
   0.0%
8
   0.6%
2
   0.3%
Any Redness, Dose 3 Number Analyzed 1407 participants 699 participants 1378 participants 710 participants
42
   3.0%
13
   1.9%
113
   8.2%
63
   8.9%
Grade 3 Redness, Dose 3 Number Analyzed 1407 participants 699 participants 1378 participants 710 participants
2
   0.1%
0
   0.0%
1
   0.1%
1
   0.1%
Any Swelling, Dose 3 Number Analyzed 1407 participants 699 participants 1378 participants 710 participants
134
   9.5%
35
   5.0%
185
  13.4%
111
  15.6%
Grade 3 Swelling, Dose 3 Number Analyzed 1407 participants 699 participants 1378 participants 710 participants
9
   0.6%
0
   0.0%
9
   0.7%
12
   1.7%
Any Pain, Across doses Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
401
  27.1%
105
  14.6%
705
  48.2%
342
  46.3%
Grade 3 Pain, Across doses Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
3
   0.2%
0
   0.0%
23
   1.6%
12
   1.6%
Any Redness, Across doses Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
122
   8.2%
49
   6.8%
292
  20.0%
163
  22.1%
Grade 3 Redness, Across doses Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
6
   0.4%
0
   0.0%
7
   0.5%
5
   0.7%
Any Swelling, Across doses Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
303
  20.5%
119
  16.5%
427
  29.2%
248
  33.6%
Grade 3 Swelling, Across doses Number Analyzed 1479 participants 721 participants 1462 participants 738 participants
25
   1.7%
0
   0.0%
59
   4.0%
53
   7.2%
42.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine and had their symptom sheets filled in.
Arm/Group Title GSK257049 [5-17M] Group GSK257049 [6-12W] Group VeroRab Comparator [5-17M] Group Menjugate Comparator [6-12W] Group
Hide Arm/Group Description:
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Number of Participants Analyzed 1479 1462 721 738
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
91
   6.2%
164
  11.2%
27
   3.7%
65
   8.8%
Grade 3 Drowsiness, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
3
   0.2%
1
   0.1%
0
   0.0%
1
   0.1%
Related Drowsiness, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
33
   2.2%
88
   6.0%
8
   1.1%
26
   3.5%
Any Irritability, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
165
  11.2%
370
  25.3%
41
   5.7%
157
  21.3%
Grade 3 Irritability, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
0
   0.0%
10
   0.7%
0
   0.0%
3
   0.4%
Related Irritability, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
64
   4.3%
226
  15.5%
16
   2.2%
84
  11.4%
Any Loss of appetite, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
202
  13.7%
124
   8.5%
71
   9.8%
52
   7.0%
Grade 3 Loss of appetite, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
3
   0.2%
2
   0.1%
0
   0.0%
0
   0.0%
Related Loss of appetite, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
71
   4.8%
67
   4.6%
24
   3.3%
24
   3.3%
Any Fever, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
385
  26.0%
459
  31.4%
108
  15.0%
192
  26.0%
Grade 3 Fever, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
29
   2.0%
5
   0.3%
7
   1.0%
2
   0.3%
Related Fever, Dose 1 Number Analyzed 1479 participants 1462 participants 721 participants 738 participants
200
  13.5%
326
  22.3%
52
   7.2%
127
  17.2%
Any Drowsiness, Dose 2 Number Analyzed 1435 participants 1412 participants 708 participants 721 participants
99
   6.9%