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Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.

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ClinicalTrials.gov Identifier: NCT00380393
Recruitment Status : Completed
First Posted : September 26, 2006
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Malaria
Interventions Biological: GSK malaria vaccine 257049 Vaccine
Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine
Enrollment 894
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60. Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Period Title: Month 8 (Cross-sectional Visit)
Started 447 447
Completed 398 407
Not Completed 49 40
Reason Not Completed
Withdrawal by Subject             6             5
Lost to Follow-up             0             1
Migrated/moved from study area             37             29
Serious Adverse Event             1             1
Others             5             4
Period Title: Month 14
Started 447 447
Completed 390 391
Not Completed 57 56
Reason Not Completed
Withdrawal by Subject             9             7
Death             1             0
Lost to Follow-up             0             1
Migrated/moved from study area             39             42
Protocol Violation             2             0
Others             6             6
Arm/Group Title GSK257049 Group Rabipur Group Total
Hide Arm/Group Description Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60. Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60. Total of all reporting groups
Overall Number of Baseline Participants 447 447 894
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 447 participants 447 participants 894 participants
11.4  (3.6) 11.4  (3.4) 11.4  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 447 participants 447 participants 894 participants
Female
229
  51.2%
222
  49.7%
451
  50.4%
Male
218
  48.8%
225
  50.3%
443
  49.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Frequency of First Case of Malaria Meeting the Primary Case Definition
Hide Description The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
Time Frame Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 415 420
Measure Type: Number
Unit of Measure: PYAR
With estimate of VE adjusted for covariates Number Analyzed 402 participants 407 participants
244.77 238.51
With estimate of VE unadjusted for covariates Number Analyzed 415 participants 420 participants
249.23 242.06
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK257049 Group, Rabipur Group
Comments Vaccine efficacy against P. falciparum
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 52.9
Confidence Interval (2-Sided) 95%
28.1 to 69.1
Estimation Comments Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK257049 Group, Rabipur Group
Comments Vaccine efficacy against P. falciparum
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 55.0
Confidence Interval (2-Sided) 95%
31.4 to 70.4
Estimation Comments Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.
2.Secondary Outcome
Title Frequency of First Case Malaria Meeting the Secondary Case Definition
Hide Description The first case of malaria meeting the secondary case definition was defined as the first or only episodes with the presence of P.falciparum asexual parasitemia > 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
Time Frame Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 415 420
Measure Type: Number
Unit of Measure: PYAR
With estimate of VE adjusted for covariates Number Analyzed 402 participants 407 participants
244.72 237.21
With estimate of VE unadjusted for covariates Number Analyzed 415 participants 420 participants
249.17 240.76
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK257049 Group, Rabipur Group
Comments Vaccine efficacy against P. falciparum.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 54.6
Confidence Interval (2-Sided) 95%
31.2 to 70.0
Estimation Comments Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK257049 Group, Rabipur Group
Comments Vaccine efficacy against P. falciparum.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 56.5
Confidence Interval (2-Sided) 95%
34.2 to 71.2
Estimation Comments Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.
3.Secondary Outcome
Title Multiple Events of Malaria Meeting the Primary Case Definition
Hide Description Multiple episodes of malaria meeting the primary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia > 25000 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of primary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
Time Frame Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 415 420
Measure Type: Number
Unit of Measure: PYAR
With estimate of VE adjusted for covariates Number Analyzed 402 participants 407 participants
253.69 255.36
With estimate of VE unadjusted for covariates Number Analyzed 415 participants 420 participants
258.15 259.61
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK257049 Group, Rabipur Group
Comments Vaccine efficacy against P. falciparum.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 55.8
Confidence Interval (2-Sided) 95%
31.0 to 71.7
Estimation Comments Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK257049 Group, Rabipur Group
Comments Vaccine efficacy against P. falciparum.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 57.9
Confidence Interval (2-Sided) 95%
34.3 to 73.0
Estimation Comments Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.
4.Secondary Outcome
Title Multiple Events of Malaria Meeting the Secondary Case Definition
Hide Description Multiple episodes of malaria meeting the secondary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia > 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of secondary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
Time Frame Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 415 420
Measure Type: Number
Unit of Measure: PYAR
With estimate of VE adjusted for covariates Number Analyzed 402 participants 407 participants
253.62 255.06
With estimate of VE unadjusted for covariates Number Analyzed 415 participants 420 participants
258.07 259.31
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK257049 Group, Rabipur Group
Comments Vaccine efficacy against P. falciparum.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 58.0
Confidence Interval (2-Sided) 95%
34.8 to 73.0
Estimation Comments Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK257049 Group, Rabipur Group
Comments Vaccine efficacy against P. falciparum.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 59.5
Confidence Interval (2-Sided) 95%
37.1 to 73.9
Estimation Comments Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.
5.Secondary Outcome
Title Number of Subjects Positive for P. Falciparum Parasitaemia
Hide Description [Not Specified]
Time Frame At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 380 390
Measure Type: Count of Participants
Unit of Measure: Participants
7
   1.8%
11
   2.8%
6.Secondary Outcome
Title Geometric Mean Density of Asexual P. Falciparum Parasite
Hide Description Estimates of asexual P. falciparum parasite density were made at the investigator's sites according to laboratory standard operating procedures. Parasite density was presented as a geometric mean (GMean), expressed in parasite per microliters (μL).
Time Frame At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 380 390
Geometric Mean (95% Confidence Interval)
Unit of Measure: parasites/μL
1020
(135 to 7720)
3486
(557 to 21813)
7.Secondary Outcome
Title Haemoglobin Values at Cross-Sectional Visit
Hide Description Haemoglobin values are expressed in grams per deciliter (g/dL).
Time Frame At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 379 388
Mean (Standard Deviation)
Unit of Measure: g/dL
10.32  (1.01) 10.37  (1.03)
8.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 447 participants 447 participants
51
  11.4%
39
   8.7%
Grade 3 Pain, Dose 1 Number Analyzed 447 participants 447 participants
0
   0.0%
0
   0.0%
Swelling Pain, Dose 1 Number Analyzed 447 participants 447 participants
20
   4.5%
12
   2.7%
Swelling 3 Pain, Dose 1 Number Analyzed 447 participants 447 participants
0
   0.0%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 439 participants 438 participants
45
  10.3%
38
   8.7%
Grade 3 Pain, Dose 2 Number Analyzed 439 participants 438 participants
0
   0.0%
0
   0.0%
Swelling Pain, Dose 2 Number Analyzed 439 participants 438 participants
6
   1.4%
3
   0.7%
Swelling 3 Pain, Dose 2 Number Analyzed 439 participants 438 participants
1
   0.2%
0
   0.0%
Any Pain, Dose 3 Number Analyzed 434 participants 433 participants
76
  17.5%
80
  18.5%
Grade 3 Pain, Dose 3 Number Analyzed 434 participants 433 participants
0
   0.0%
0
   0.0%
Swelling Pain, Dose 3 Number Analyzed 434 participants 433 participants
8
   1.8%
1
   0.2%
Swelling 3 Pain, Dose 3 Number Analyzed 434 participants 433 participants
2
   0.5%
0
   0.0%
Any Pain, Across doses Number Analyzed 447 participants 447 participants
143
  32.0%
130
  29.1%
Grade 3 Pain, Across doses Number Analyzed 447 participants 447 participants
0
   0.0%
0
   0.0%
Swelling Pain, Across doses Number Analyzed 447 participants 447 participants
30
   6.7%
13
   2.9%
Swelling 3 Pain, Across doses Number Analyzed 447 participants 447 participants
3
   0.7%
0
   0.0%
9.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness, Dose 1 Number Analyzed 447 participants 447 participants
44
   9.8%
28
   6.3%
Grade 3 Drowsiness, Dose 1 Number Analyzed 447 participants 447 participants
0
   0.0%
0
   0.0%
Related Drowsiness, Dose 1 Number Analyzed 447 participants 447 participants
32
   7.2%
27
   6.0%
Any Fever, Dose 1 Number Analyzed 447 participants 447 participants
55
  12.3%
138
  30.9%
Grade 3 Fever, Dose 1 Number Analyzed 447 participants 447 participants
1
   0.2%
2
   0.4%
Related Fever, Dose 1 Number Analyzed 447 participants 447 participants
49
  11.0%
133
  29.8%
Any Irritability, Dose 1 Number Analyzed 447 participants 447 participants
26
   5.8%
12
   2.7%
Grade 3 Irritability, Dose 1 Number Analyzed 447 participants 447 participants
0
   0.0%
0
   0.0%
Related Irritability, Dose 1 Number Analyzed 447 participants 447 participants
17
   3.8%
8
   1.8%
Any Loss of appetite, Dose 1 Number Analyzed 447 participants 447 participants
34
   7.6%
28
   6.3%
Grade 3 Loss of appetite, Dose 1 Number Analyzed 447 participants 447 participants
0
   0.0%
1
   0.2%
Related Loss of appetite, Dose 1 Number Analyzed 447 participants 447 participants
14
   3.1%
9
   2.0%
Any Drowsiness, Dose 2 Number Analyzed 439 participants 438 participants
22
   5.0%
25
   5.7%
Grade 3 Drowsiness, Dose 2 Number Analyzed 439 participants 438 participants
0
   0.0%
1
   0.2%
Related Drowsiness, Dose 2 Number Analyzed 439 participants 438 participants
22
   5.0%
23
   5.3%
Any Fever, Dose 2 Number Analyzed 439 participants 438 participants
56
  12.8%
159
  36.3%
Grade 3 Fever, Dose 2 Number Analyzed 439 participants 438 participants
3
   0.7%
8
   1.8%
Related Fever, Dose 2 Number Analyzed 439 participants 438 participants
51
  11.6%
156
  35.6%
Any Irritability, Dose 2 Number Analyzed 439 participants 438 participants
16
   3.6%
7
   1.6%
Grade 3 Irritability, Dose 2 Number Analyzed 439 participants 438 participants
0
   0.0%
0
   0.0%
Related Irritability, Dose 2 Number Analyzed 439 participants 438 participants
14
   3.2%
7
   1.6%
Any Loss of appetite, Dose 2 Number Analyzed 439 participants 438 participants
24
   5.5%
13
   3.0%
Grade 3 Loss of appetite, Dose 2 Number Analyzed 439 participants 438 participants
0
   0.0%
1
   0.2%
Related Loss of appetite, Dose 2 Number Analyzed 439 participants 438 participants
12
   2.7%
7
   1.6%
Any Drowsiness, Dose 3 Number Analyzed 434 participants 433 participants
15
   3.5%
11
   2.5%
Grade 3 Drowsiness, Dose 3 Number Analyzed 434 participants 433 participants
0
   0.0%
0
   0.0%
Related Drowsiness, Dose 3 Number Analyzed 434 participants 433 participants
15
   3.5%
10
   2.3%
Any Fever, Dose 3 Number Analyzed 434 participants 433 participants
38
   8.8%
112
  25.9%
Grade 3 Fever, Dose 3 Number Analyzed 434 participants 433 participants
1
   0.2%
2
   0.5%
Related Fever, Dose 3 Number Analyzed 434 participants 433 participants
32
   7.4%
107
  24.7%
Any Irritability, Dose 3 Number Analyzed 434 participants 433 participants
17
   3.9%
2
   0.5%
Grade 3 Irritability, Dose 3 Number Analyzed 434 participants 433 participants
0
   0.0%
0
   0.0%
Related Irritability, Dose 3 Number Analyzed 434 participants 433 participants
13
   3.0%
1
   0.2%
Any Loss of appetite, Dose 3 Number Analyzed 434 participants 433 participants
6
   1.4%
2
   0.5%
Grade 3 Loss of appetite, Dose 3 Number Analyzed 434 participants 433 participants
0
   0.0%
0
   0.0%
Related Loss of appetite, Dose 3 Number Analyzed 434 participants 433 participants
3
   0.7%
0
   0.0%
Any Drowsiness, Across Doses Number Analyzed 447 participants 447 participants
66
  14.8%
59
  13.2%
Grade 3 Drowsiness, Across Doses Number Analyzed 447 participants 447 participants
0
   0.0%
1
   0.2%
Related Drowsiness, Across Doses Number Analyzed 447 participants 447 participants
55
  12.3%
56
  12.5%
Any Fever, Across Doses Number Analyzed 447 participants 447 participants
125
  28.0%
268
  60.0%
Grade 3 Fever, Across Doses Number Analyzed 447 participants 447 participants
5
   1.1%
12
   2.7%
Related Fever, Across Doses Number Analyzed 447 participants 447 participants
111
  24.8%
262
  58.6%
Any Irritability, Across Doses Number Analyzed 447 participants 447 participants
45
  10.1%
19
   4.3%
Grade 3 Irritability, Across Doses Number Analyzed 447 participants 447 participants
0
   0.0%
0
   0.0%
Related Irritability, Across Doses Number Analyzed 447 participants 447 participants
33
   7.4%
14
   3.1%
Any Loss of appetite, Across Doses Number Analyzed 447 participants 447 participants
54
  12.1%
40
   8.9%
Grade 3 Loss of appetite, Across Doses Number Analyzed 447 participants 447 participants
0
   0.0%
2
   0.4%
Related Loss of appetite, Across Doses Number Analyzed 447 participants 447 participants
28
   6.3%
14
   3.1%
10.Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame Within the 30-day (Days 0-29) post-vaccination follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
349
  78.1%
332
  74.3%
11.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Throughout the study period (Day 0 - Month 14)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
51
  11.4%
88
  19.7%
12.Secondary Outcome
Title Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades
Hide Description Definitions for toxicity grading for hemoglobin were: Normal Hemoglobin = equal to or above (≥) 8.0 g/dL; Grade 1 Hemoglobin = under (<) 8.0 g/dL and above (>) 6.0 g/dL.; Grade 2 Hemoglobin = under (<) 6.0 g/dL.
Time Frame At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
At Day 0 Normal
445
  99.6%
446
  99.8%
Grade 1
1
   0.2%
1
   0.2%
Grade 2
1
   0.2%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
At Month 3 Normal
410
  91.7%
413
  92.4%
Grade 1
7
   1.6%
10
   2.2%
Grade 2
0
   0.0%
0
   0.0%
Missing
30
   6.7%
24
   5.4%
At Cross-sectional Visit Normal
391
  87.5%
397
  88.8%
Grade 1
6
   1.3%
8
   1.8%
Grade 2
0
   0.0%
0
   0.0%
Missing
50
  11.2%
42
   9.4%
13.Secondary Outcome
Title Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades
Hide Description Definitions for toxicity grading for WBC were: Normal WBC = ≥ 4.0 x 10^3 cells per microliters (cells/μL) or < 17 x 10^3 cells /μL; Grade 1 WBC = 2.5 to 4.0 x 10^3 cells/μL.
Time Frame At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
At Day 0 Normal
447
 100.0%
447
 100.0%
Grade 1
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
At Month 3 Normal
416
  93.1%
422
  94.4%
Grade 1
0
   0.0%
1
   0.2%
Missing
31
   6.9%
24
   5.4%
At Cross-sectional Visit Normal
395
  88.4%
405
  90.6%
Grade 1
0
   0.0%
0
   0.0%
Missing
52
  11.6%
42
   9.4%
14.Secondary Outcome
Title Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades
Hide Description Definitions for toxicity grading for platelets were: Normal Platelets = ≥ 75 x 10^3 cells/μL; Grade 1 Platelets = 50 to 74 x 10^3 /μL; Grade 2 Platelets = 25 to 49 x 10^3 /μL; Grade 3 Platelets = < 25 x 10^3 /μL.
Time Frame At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
At Day 0 Normal
445
  99.6%
447
 100.0%
Grade 1
1
   0.2%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Missing
1
   0.2%
0
   0.0%
At Month 3 Normal
414
  92.6%
417
  93.3%
Grade 1
1
   0.2%
0
   0.0%
Grade 2
2
   0.4%
4
   0.9%
Grade 3
0
   0.0%
1
   0.2%
Missing
30
   6.7%
25
   5.6%
At Cross-sectional Visit Normal
386
  86.4%
396
  88.6%
Grade 1
4
   0.9%
1
   0.2%
Grade 2
1
   0.2%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Missing
56
  12.5%
50
  11.2%
15.Secondary Outcome
Title Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades
Hide Description Definition for toxicity grading for ALT were: Normal ALT = ≤ 60 international units per liter (IU/L); Grade 1 ALT = 1.1 to 2.5 x Upper Limit of Normal (ULN); Grade 2 ALT = 2.6 to 5.0 x ULN.
Time Frame At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
At Day 0 Normal
446
  99.8%
447
 100.0%
Grade 1
1
   0.2%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
At Month 3 Normal
413
  92.4%
420
  94.0%
Grade 1
1
   0.2%
2
   0.4%
Grade 2
0
   0.0%
1
   0.2%
Missing
33
   7.4%
24
   5.4%
At Cross-sectional Visit Normal
393
  87.9%
397
  88.8%
Grade 1
5
   1.1%
8
   1.8%
Grade 2
0
   0.0%
1
   0.2%
Missing
49
  11.0%
41
   9.2%
16.Secondary Outcome
Title Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades
Hide Description Definition for toxicity grading for creatinine were: Normal Creatinine = ≤ 60 micromols per liter (μmol/L); Grade 1 Creatinine = 1.1 to 1.5 x ULN; Grade 2 Creatinine = 1.6 to 3.0 x ULN.
Time Frame At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 447 447
Measure Type: Count of Participants
Unit of Measure: Participants
At Day 0 Normal
447
 100.0%
447
 100.0%
Grade 1
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
At Month 3 Normal
415
  92.8%
422
  94.4%
Grade 1
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
Missing
32
   7.2%
25
   5.6%
At Cross-sectional Visit Normal
397
  88.8%
405
  90.6%
Grade 1
1
   0.2%
0
   0.0%
Grade 2
0
   0.0%
1
   0.2%
Missing
49
  11.0%
41
   9.2%
17.Secondary Outcome
Title Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS)
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).
Time Frame At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 411 419
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
At Day 0 Number Analyzed 411 participants 419 participants
0.3
(0.3 to 0.3)
0.3
(0.3 to 0.3)
At Month 3 Number Analyzed 390 participants 401 participants
539.6
(500.7 to 581.6)
0.3
(0.3 to 0.3)
At Cross-sectional Visit Number Analyzed 366 participants 384 participants
71.9
(65.7 to 78.6)
0.3
(0.2 to 0.3)
18.Secondary Outcome
Title Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs)
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).
Time Frame At Day 0 and at Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 410 419
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
At Day 0 Number Analyzed 410 participants 419 participants
155.4
(134.6 to 179.5)
187.4
(161.8 to 217.0)
At Month 3 Number Analyzed 390 participants 400 participants
46776.3
(39018.3 to 56076.8)
168.0
(145.6 to 193.8)
19.Secondary Outcome
Title Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells
Hide Description T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).
Time Frame Prior to vaccination (Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 168 183
Median (Inter-Quartile Range)
Unit of Measure: cells/million
CD4-IFN-γ
15
(1 to 55)
14
(1 to 56)
CD4-IL-2
111
(59 to 166)
113
(53 to 212)
CD4-TNF-α
94
(40 to 218)
92
(40 to 238)
20.Secondary Outcome
Title Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells
Hide Description T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).
Time Frame Prior to vaccination (Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 161 165
Median (Inter-Quartile Range)
Unit of Measure: cells/million
CD8-IFN-γ
1
(1 to 56)
37
(1 to 90)
CD8-IL-2
219
(117 to 417)
222
(98 to 395)
CD8-TNF-α
100
(35 to 254)
82
(37 to 203)
21.Secondary Outcome
Title Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells
Hide Description T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).
Time Frame At Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 156 169
Median (Inter-Quartile Range)
Unit of Measure: cells/million
CD4-IFN-γ
33
(13 to 94)
13
(1 to 79)
CD4-IL-2
648
(359 to 1342)
139
(66 to 463)
CD4-TNF-α
416
(225 to 755)
172
(66 to 460)
22.Secondary Outcome
Title Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells
Hide Description T-cells expressing at least one of the following cytokines are presented here: interleukin-2 [IL-2], tumor-necrosis factor-alpha [TNF-α] and interferon-gamma [IFN-γ]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).
Time Frame At Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description:
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Overall Number of Participants Analyzed 143 156
Median (Inter-Quartile Range)
Unit of Measure: cells/million
CD8-IFN-γ
36
(1 to 158)
32
(1 to 160)
CD8-IL-2
248
(131 to 428)
219
(96 to 459)
CD8-TNF-α
201
(104 to 407)
185
(68 to 390)
Time Frame Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK257049 Group Rabipur Group
Hide Arm/Group Description Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60. Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
All-Cause Mortality
GSK257049 Group Rabipur Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/447 (0.22%)      0/447 (0.00%)    
Hide Serious Adverse Events
GSK257049 Group Rabipur Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/447 (11.41%)      88/447 (19.69%)    
Blood and lymphatic system disorders     
Anaemia  1  5/447 (1.12%)  5 11/447 (2.46%)  12
Cardiac disorders     
Mitral valve disease  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Congenital, familial and genetic disorders     
Sickle cell anaemia  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Sickle cell anaemia with crisis  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Ventricular septal defect  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Eye disorders     
Conjunctivitis  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Gastrointestinal disorders     
Rectal prolapse  1  0/447 (0.00%)  0 2/447 (0.45%)  2
General disorders     
Pyrexia  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Infections and infestations     
Abscess  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Acarodermatitis  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Bronchiolitis  1  1/447 (0.22%)  1 3/447 (0.67%)  3
Bronchitis  1  1/447 (0.22%)  1 1/447 (0.22%)  1
Cellulitis  1  1/447 (0.22%)  1 1/447 (0.22%)  1
Cerebral malaria  1  0/447 (0.00%)  0 3/447 (0.67%)  3
Cholera  1  1/447 (0.22%)  1 2/447 (0.45%)  2
Dysentery  1  2/447 (0.45%)  2 1/447 (0.22%)  1
Escherichia sepsis  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Extrapulmonary tuberculosis  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Gastroenteritis  1  10/447 (2.24%)  10 22/447 (4.92%)  22
Impetigo  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Lower respiratory tract infection  1  1/447 (0.22%)  1 1/447 (0.22%)  1
Otitis media  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Otitis media acute  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Plasmodium falciparum infection  1  8/447 (1.79%)  8 25/447 (5.59%)  25
Pneumococcal sepsis  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Pneumonia  1  16/447 (3.58%)  18 26/447 (5.82%)  28
Rhinitis  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Schistosomiasis  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Skin infection  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Streptococcal sepsis  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Subcutaneous abscess  1  1/447 (0.22%)  1 1/447 (0.22%)  1
Tinea capitis  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Tonsillitis  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Upper respiratory tract infection  1  8/447 (1.79%)  8 4/447 (0.89%)  5
Urinary tract infection  1  3/447 (0.67%)  3 0/447 (0.00%)  0
Varicella  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Injury, poisoning and procedural complications     
Burns first degree  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Drug toxicity  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Femur fracture  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Petroleum distillate poisoning  1  0/447 (0.00%)  0 2/447 (0.45%)  2
Thermal burn  1  0/447 (0.00%)  0 2/447 (0.45%)  2
Metabolism and nutrition disorders     
Kwashiorkor  1  0/447 (0.00%)  0 1/447 (0.22%)  2
Malnutrition  1  1/447 (0.22%)  1 2/447 (0.45%)  2
Marasmus  1  0/447 (0.00%)  0 2/447 (0.45%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant mesenchymoma  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Nervous system disorders     
Convulsion  1  3/447 (0.67%)  3 2/447 (0.45%)  2
Epilepsy  1  0/447 (0.00%)  0 1/447 (0.22%)  1
Febrile convulsion  1  14/447 (3.13%)  17 20/447 (4.47%)  24
Respiratory, thoracic and mediastinal disorders     
Asthma  1  2/447 (0.45%)  2 1/447 (0.22%)  1
Bronchial hyperreactivity  1  0/447 (0.00%)  0 2/447 (0.45%)  2
Foreign body aspiration  1  1/447 (0.22%)  1 0/447 (0.00%)  0
Vascular disorders     
Shock  1  0/447 (0.00%)  0 1/447 (0.22%)  1
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK257049 Group Rabipur Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   385/447 (86.13%)      396/447 (88.59%)    
General disorders     
Pain  1  143/447 (31.99%)  172 130/447 (29.08%)  157
Pyrexia  1  125/447 (27.96%)  149 268/447 (59.96%)  409
Swelling  1  30/447 (6.71%)  34 14/447 (3.13%)  17
Infections and infestations     
Gastroenteritis  1  101/447 (22.60%)  120 81/447 (18.12%)  90
Impetigo  1  27/447 (6.04%)  28 19/447 (4.25%)  20
Lower respiratory tract infection  1  27/447 (6.04%)  27 28/447 (6.26%)  28
Pneumonia  1  149/447 (33.33%)  195 141/447 (31.54%)  188
Rhinitis  1  27/447 (6.04%)  28 18/447 (4.03%)  20
Upper respiratory tract infection  1  81/447 (18.12%)  96 56/447 (12.53%)  59
Metabolism and nutrition disorders     
Decreased appetite  1  54/447 (12.08%)  64 40/447 (8.95%)  43
Nervous system disorders     
Somnolence  1  66/447 (14.77%)  81 59/447 (13.20%)  64
Psychiatric disorders     
Irritability  1  45/447 (10.07%)  59 19/447 (4.25%)  21
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00380393    
Other Study ID Numbers: 106464
First Submitted: September 25, 2006
First Posted: September 26, 2006
Results First Submitted: August 25, 2017
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018