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Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00436007
Recruitment Status : Completed
First Posted : February 16, 2007
Results First Posted : May 27, 2013
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Malaria
Interventions Biological: GSK 257049
Biological: Tritanrix™ HepB/Hib
Biological: Rouvax™
Biological: Stamaril™
Biological: Polio Sabin™
Enrollment 511
Recruitment Details  
Pre-assignment Details The study comprised a vaccination phase (Months 0-8) and a follow-up phase (Months 8-19). The Stamaril™ vaccine was not part of the EPI Tanzanian vaccination schedule at study planning. Hence this vaccine was not administered to subjects from Tanzania.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Period Title: Overall Study
Started 170 170 171
Completed 151 156 148
Not Completed 19 14 23
Reason Not Completed
Withdrawal by Subject             5             3             4
Lost to Follow-up             14             10             13
Physician Decision             0             0             2
Death             0             1             3
Other             0             0             1
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group Total
Hide Arm/Group Description

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. Total of all reporting groups
Overall Number of Baseline Participants 170 170 171 511
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 170 participants 170 participants 171 participants 511 participants
7.0  (0.97) 7.1  (1.05) 7.0  (0.97) 7.0  (1.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 170 participants 171 participants 511 participants
Female
90
  52.9%
84
  49.4%
78
  45.6%
252
  49.3%
Male
80
  47.1%
86
  50.6%
93
  54.4%
259
  50.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 170 participants 170 participants 171 participants 511 participants
Gabon 73 73 74 220
Ghana 27 27 27 81
Tanzania 70 70 70 210
1.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame From Month 0 to Month 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 170 170 171
Measure Type: Number
Unit of Measure: subjects
38 28 33
2.Secondary Outcome
Title Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Hide Description Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 1 Group.
Time Frame At Months 0, 1, 3 and 7.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 1 Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Overall Number of Participants Analyzed 145
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HB, Month 0 [N=145]
12.5
(9.9 to 15.7)
Anti-HB, Month 1 [N=133]
173.4
(131.9 to 228.0)
Anti-HB, Month 3 [N=130]
1355.7
(1100.6 to 1669.9)
Anti-HB, Month 7 [N=137]
1555.5
(1315.8 to 1839.0)
3.Secondary Outcome
Title Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Hide Description Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the GSK 257049 2 Group.
Time Frame At Months 0, 3, 7 and 8.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 2 Group
Hide Arm/Group Description:
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HB, Month 0 [N=131]
9.6
(7.8 to 11.8)
Anti-HB, Month 3 [N=119]
651.2
(541.1 to 783.8)
Anti-HB, Month 7 [N=126]
1133.1
(972.3 to 1320.6)
Anti-HB, Month 8 [N=125]
59813.5
(47050.5 to 76038.6)
4.Secondary Outcome
Title Concentrations of Antibodies Against Hepatitis B (Anti-HB Antibodies).
Hide Description Anti-HB antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection assay cut-off was 10 mIU/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.
Time Frame At Months 0, 3, 7 and 8.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 143
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HB, Month 0 [N=143]
8.7
(7.3 to 10.5)
Anti-HB, Month 3 [N=126]
338.0
(266.3 to 429.0)
Anti-HB, Month 7 [N=131]
159.9
(127.0 to 201.3)
Anti-HB, Month 8 [N=133]
162.4
(127.9 to 206.3)
5.Secondary Outcome
Title Concentrations of Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Hide Description Anti-D and Anti-T antibody concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection assay cut-off was 0.1 IU/mL.
Time Frame At Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania
Overall Number of Participants Analyzed 142 133 142
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D
1.0
(0.9 to 1.2)
1.1
(0.9 to 1.3)
1.4
(1.2 to 1.7)
Anti-T
2.8
(2.3 to 3.3)
2.6
(2.2 to 3.1)
3.7
(3.2 to 4.3)
6.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame From Month 8 to Month 19
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 170 170 171
Measure Type: Number
Unit of Measure: subjects
28 24 27
7.Secondary Outcome
Title Concentrations of Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibodies.
Hide Description Anti-PRP antibody concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection assay cut-off was 0.15 µg/mL.
Time Frame At Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 141 132 142
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
13.3
(10.5 to 16.7)
15.7
(12.6 to 19.4)
18.6
(14.8 to 23.5)
8.Secondary Outcome
Title Titers for Antibodies Against Poliomyelitis Types 1, 2 and 3 (Anti-Polio 1, 2 and 3 Antibodies).
Hide Description Anti-Polio 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 8.
Time Frame At Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 136 125 133
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
Anti-Polio 1 [N=136;125;131]
463.6
(342.8 to 627.0)
485.5
(342.5 to 688.3)
500.0
(365.0 to 684.9)
Anti-Polio 2 [N=135;124;131]
494.0
(389.7 to 626.2)
563.2
(457.3 to 693.6)
406.8
(329.1 to 502.9)
Anti-Polio 3 [N=135;125;133]
123.5
(92.1 to 165.6)
148.7
(112.2 to 197.0)
205.1
(156.5 to 268.7)
9.Secondary Outcome
Title Concentrations of Anti-Bordetella Pertussis Toxin (Anti-BPT) Antibodies.
Hide Description Anti-BPT antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 15 EL.U/mL.
Time Frame At Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 139 131 139
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
85.3
(76.8 to 94.6)
104.4
(94.8 to 115.0)
106.5
(96.1 to 118.1)
10.Secondary Outcome
Title Concentrations of Anti-measles Antibodies.
Hide Description Anti-measles antibody concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seropositivity assay cut-off was 150 mIU/mL. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.
Time Frame At Months 7 and 8.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 119 122
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-measles, Month 7 [N=112;120]
75.0
(75.0 to 75.0)
1295.2
(1052.1 to 1594.5)
Anti-measles, Month 8 [N=119;122]
76.2
(73.8 to 78.6)
1299.0
(1038.8 to 1624.4)
11.Secondary Outcome
Title Titers for Anti-yellow Fever Antibodies.
Hide Description

Anti-yellow fever antibody titers were expressed as geometric mean titers (GMTs). The seroprotection assay cut-off was 10. The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.

The analysis was only performed on subjects from the GSK 257049 2 and Tritanrix™ HepB/Hiberix™ groups.

Time Frame At Months 7 and 8.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 62 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
Anti-yellow fever, Month 7 [N=41;62]
5.3
(4.8 to 5.8)
5.9
(5.1 to 6.9)
Anti-yellow fever, Month 8 [N=46;64]
172.2
(135.9 to 236.3)
183.4
(134.0 to 250.9)
12.Secondary Outcome
Title Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Hide Description Anti-CS antibody antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 1 Group.
Time Frame At Months 0, 1, 3 and 7.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 1 Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Overall Number of Participants Analyzed 153
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Month 0 [N=153]
0.4
(0.3 to 0.4)
Anti-CS, Month 2 [N=137]
86.6
(66.5 to 112.7)
Anti-CS, Month 3 [N=131]
190.3
(154.3 to 234.7)
Anti-CS, Month 7 [N=137]
35.3
(28.5 to 43.8)
13.Secondary Outcome
Title Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Hide Description Anti-CS antiibodies were measured by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the GSK 257049 2 Group.
Time Frame At Months 0, 3, 7 and 8.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK 257049 2 Group
Hide Arm/Group Description:
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 141
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Month 0 [N=141]
0.4
(0.3 to 0.4)
Anti-CS, Month 3 [N=121]
57.7
(43.7 to 76.2)
Anti-CS, Month 7 [N=127]
6.1
(4.6 to 7.9)
Anti-CS, Month 8 [N=127]
107.8
(81.1 to 143.4)
14.Secondary Outcome
Title Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Hide Description Anti-CS antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity assay cut-off was 0.5 EL.U/mL. This outcome only covers results for the Tritanrix™ HepB/Hiberix™ Group.
Time Frame At Months 0, 3, 7 and 8.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 156
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, Month 0 [N=156]
0.4
(0.3 to 0.4)
Anti-CS, Month 3 [N=129]
0.3
(0.3 to 0.3)
Anti-CS, Month 7 [N=132]
0.3
(0.3 to 0.3)
Anti-CS, Month 8 [N=135]
0.3
(0.3 to 0.3)
15.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms.
Hide Description Assessed solicited local symptoms were pain and swelling at injection site following vaccination with each of the following study vaccines administered intramuscularly, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines. The numbers of subjects with each of the assessed solicited local symptoms reported were tabulated for each vaccine administered, separately.
Time Frame During the 7-day (Days 0-6) follow-up period after any vaccination with the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049 and Stamaril™ vaccines.
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 170 170 171
Measure Type: Number
Unit of Measure: subjects
Pain - GSK 257049 [N=170;170;0] 126 116 NA [1] 
Swelling - GSK 257049 [N=170;170;0] 28 44 NA [1] 
Pain - Rouvax™ [N=163;161;159] 52 54 47
Swelling - Rouvax™ [N=163;161;159] 20 21 16
Pain - Stamaril™ [N=95;94;94] 2 7 2
Swelling - Stamaril™ [N=95;94;94] 0 1 0
Pain - Tritanrix™ HepB/Hib [N=170;170;171] 127 133 140
Swelling - Tritanrix™ HepB/Hib [N=170;170;171] 47 68 68
[1]
The GSK 257049 vaccine was not administered to subjects from the Tritanrix™ HepB/Hiberix™ Group group.
16.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms.
Hide Description Assessed solicited general symptoms were drowsiness, fever [axillary temperature equal or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite following any vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.
Time Frame During the 7-day (Days 0-6) follow-up period after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects whose symptom sheet was completed.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 170 170 171
Measure Type: Number
Unit of Measure: subjects
Drowsiness 82 97 72
Fever (axillary temperature ≥ 37.5°C) 102 95 75
Irritability 124 131 118
Loss of appetite 68 83 70
17.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Unsolicited AEs were assessed following vaccination with any of the study vaccines, e. a. the Tritanrix™ HepB/Hib, Rouvax™, GSK 257049, Stamaril™ and Polio Sabin™ vaccines.
Time Frame During the 30-day (Days 0-29) follow-up period after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 170 170 171
Measure Type: Number
Unit of Measure: subjects
160 161 164
18.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame From Month 0 to Month 19
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description:

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
Overall Number of Participants Analyzed 170 170 171
Measure Type: Number
Unit of Measure: subjects
57 47 49
Time Frame SAEs: entire study period (Months 0-19); Solicited local/general symptoms and Unsolicited AEs: during the 7- and 30-day (Days 0-29) post-vaccination period, respectively.
Adverse Event Reporting Description 3 subjects in the Tritanrix™ HepB/Hiberix™ Group died after experiencing SAEs (malnutrition (Months 0-8), and Acquired immunodeficiency syndrome, Pneumonia and Sepsis (Months 8-19)). None was assessed by the investigator to be related to study vaccines.
 
Arm/Group Title GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Hide Arm/Group Description

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.

The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.

Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania. Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
All-Cause Mortality
GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   57/170 (33.53%)   47/170 (27.65%)   49/171 (28.65%) 
Blood and lymphatic system disorders       
Anaemia * [1]  6/170 (3.53%)  10/170 (5.88%)  10/171 (5.85%) 
Microcytic anaemia * [1]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Anaemia * [2]  6/170 (3.53%)  6/170 (3.53%)  10/171 (5.85%) 
Microcytic anaemia * [2]  0/170 (0.00%)  1/170 (0.59%)  1/171 (0.58%) 
Haemolytic anaemia * [2]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Congenital, familial and genetic disorders       
Sickle cell anaemia * [1]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Sickle cell anaemia with crisis * [1]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Cataract congenital * [1]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Sickle cell anaemia with crisis * [2]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Eye disorders       
Blepharitis * [1]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Conjunctivitis * [1]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Gastrointestinal disorders       
Enteritis * [1]  1/170 (0.59%)  1/170 (0.59%)  1/171 (0.58%) 
General disorders       
Pyrexia * [1]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Pyrexia * [2]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Infections and infestations       
Gastroenteritis * [1]  17/170 (10.00%)  10/170 (5.88%)  14/171 (8.19%) 
Plasmodium falciparum infection * [1]  5/170 (2.94%)  10/170 (5.88%)  13/171 (7.60%) 
Pneumonia * [1]  11/170 (6.47%)  9/170 (5.29%)  8/171 (4.68%) 
Upper respiratory tract infection * [1]  5/170 (2.94%)  4/170 (2.35%)  4/171 (2.34%) 
Impetigo * [1]  4/170 (2.35%)  0/170 (0.00%)  3/171 (1.75%) 
Sepsis * [1]  2/170 (1.18%)  2/170 (1.18%)  3/171 (1.75%) 
Urinary tract infection * [1]  3/170 (1.76%)  2/170 (1.18%)  0/171 (0.00%) 
Otitis media * [1]  3/170 (1.76%)  0/170 (0.00%)  1/171 (0.58%) 
Acarodermatitis * [1]  0/170 (0.00%)  0/170 (0.00%)  2/171 (1.17%) 
Bronchitis * [1]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Bronchopneumonia * [1]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Escherichia urinary tract infection * [1]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Salmonella sepsis * [1]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Acquired immunodeficiency syndrome * [1]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Extrapulmonary tuberculosis * [1]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Hydrocele male infected * [1]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Mastoiditis * [1]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Otitis media acute * [1]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Periorbital abscess * [1]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Pharyngitis * [1]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Rhinitis * [1]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Skin infection * [1]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Plasmodium falciparum infection * [2]  6/170 (3.53%)  6/170 (3.53%)  14/171 (8.19%) 
Pneumonia * [2]  5/170 (2.94%)  7/170 (4.12%)  7/171 (4.09%) 
Upper respiratory tract infection * [2]  7/170 (4.12%)  4/170 (2.35%)  5/171 (2.92%) 
Gastroenteritis * [2]  7/170 (4.12%)  6/170 (3.53%)  2/171 (1.17%) 
Impetigo * [2]  1/170 (0.59%)  3/170 (1.76%)  3/171 (1.75%) 
Bronchitis * [2]  3/170 (1.76%)  2/170 (1.18%)  1/171 (0.58%) 
Urinary tract infection * [2]  3/170 (1.76%)  0/170 (0.00%)  1/171 (0.58%) 
Sepsis * [2]  1/170 (0.59%)  0/170 (0.00%)  2/171 (1.17%) 
Bronchopneumonia * [2]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Nasopharyngitis * [2]  0/170 (0.00%)  0/170 (0.00%)  2/171 (1.17%) 
Otitis media * [2]  1/170 (0.59%)  0/170 (0.00%)  1/171 (0.58%) 
Acquired immunodeficiency syndrome * [2]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Dysentery * [2]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Otitis media acute * [2]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Otitis media chronic * [2]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Pharyngitis * [2]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Pyelonephritis * [2]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Respiratory tract infection * [2]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Skin infection * [2]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Urinary tract infection pseudomonal * [2]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Injury, poisoning and procedural complications       
Thermal burn * [2]  2/170 (1.18%)  0/170 (0.00%)  0/171 (0.00%) 
Accidental exposure * [2]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Petroleum distillate poisoning * [2]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Pneumonitis chemical * [2]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * [1]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Malnutrition * [1]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Malnutrition * [2]  2/170 (1.18%)  1/170 (0.59%)  1/171 (0.58%) 
Dehydration * [2]  1/170 (0.59%)  0/170 (0.00%)  1/171 (0.58%) 
Failure to thrive * [2]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute leukaemia * [1]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Nervous system disorders       
Febrile convulsion * [1]  1/170 (0.59%)  4/170 (2.35%)  0/171 (0.00%) 
Convulsion * [1]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Convulsion * [2]  1/170 (0.59%)  0/170 (0.00%)  1/171 (0.58%) 
Febrile convulsion * [2]  0/170 (0.00%)  2/170 (1.18%)  0/171 (0.00%) 
Renal and urinary disorders       
Glomerulonephritis * [2]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * [1]  1/170 (0.59%)  1/170 (0.59%)  0/171 (0.00%) 
Bronchial hyperreactivity * [1]  0/170 (0.00%)  1/170 (0.59%)  0/171 (0.00%) 
Pneumonia aspiration * [1]  1/170 (0.59%)  0/170 (0.00%)  0/171 (0.00%) 
Asthma * [2]  1/170 (0.59%)  2/170 (1.18%)  0/171 (0.00%) 
Skin and subcutaneous tissue disorders       
Urticaria * [2]  0/170 (0.00%)  0/170 (0.00%)  1/171 (0.58%) 
*
Indicates events were collected by non-systematic assessment
[1]
SAE reported between Month 0 and Month 8.
[2]
SAE reported between Month 8 and Month 19.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK 257049 1 Group GSK 257049 2 Group Tritanrix™ HepB/Hiberix™ Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   169/170 (99.41%)   169/170 (99.41%)   171/171 (100.00%) 
Blood and lymphatic system disorders       
Anaemia *  11/170 (6.47%)  19/170 (11.18%)  11/171 (6.43%) 
Eye disorders       
Conjunctivitis *  16/170 (9.41%)  21/170 (12.35%)  19/171 (11.11%) 
Gastrointestinal disorders       
Diarrhoea *  21/170 (12.35%)  24/170 (14.12%)  24/171 (14.04%) 
General disorders       
Drowsiness   82/170 (48.24%)  97/170 (57.06%)  72/171 (42.11%) 
Fever   102/170 (60.00%)  95/170 (55.88%)  75/171 (43.86%) 
Irritability   124/170 (72.94%)  131/170 (77.06%)  118/171 (69.01%) 
Loss of appetite   68/170 (40.00%)  83/170 (48.82%)  70/171 (40.94%) 
Pain  [1]  127/170 (74.71%)  133/170 (78.24%)  140/171 (81.87%) 
Pain  [2]  52/163 (31.90%)  54/161 (33.54%)  47/159 (29.56%) 
Pain  [3]  126/170 (74.12%)  116/170 (68.24%)  0/0 
Pain  [4]  2/95 (2.11%)  7/94 (7.45%)  2/94 (2.13%) 
Swelling  [1]  47/170 (27.65%)  68/170 (40.00%)  68/171 (39.77%) 
Swelling  [2]  20/163 (12.27%)  21/161 (13.04%)  16/159 (10.06%) 
Swelling  [5]  28/170 (16.47%)  44/170 (25.88%)  0/0 
Induration *  26/170 (15.29%)  28/170 (16.47%)  29/171 (16.96%) 
Infections and infestations       
Upper respiratory tract infection *  66/170 (38.82%)  66/170 (38.82%)  65/171 (38.01%) 
Nasopharyngitis *  53/170 (31.18%)  62/170 (36.47%)  71/171 (41.52%) 
Gastroenteritis *  29/170 (17.06%)  25/170 (14.71%)  32/171 (18.71%) 
Rhinitis *  16/170 (9.41%)  21/170 (12.35%)  21/171 (12.28%) 
Pneumonia *  19/170 (11.18%)  11/170 (6.47%)  9/171 (5.26%) 
Bronchitis *  17/170 (10.00%)  17/170 (10.00%)  21/171 (12.28%) 
Respiratory, thoracic and mediastinal disorders       
Cough *  21/170 (12.35%)  30/170 (17.65%)  24/171 (14.04%) 
Rhinorrhoea *  19/170 (11.18%)  19/170 (11.18%)  23/171 (13.45%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Solicited local symptom reported after vaccination with Tritanrix™ HepB/Hib
[2]
Solicited local symptom reported after vaccination with Rouvax™.
[3]
Solicited local symptom reported after vaccination with the GSK 257049 vaccine.
[4]
Solicited local symptom reported after vaccination with Stamaril™.
[5]
Solicited local symptom reported after vaccination with the GSK 257049 vaccine
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00436007    
Other Study ID Numbers: 106369
First Submitted: February 15, 2007
First Posted: February 16, 2007
Results First Submitted: December 19, 2012
Results First Posted: May 27, 2013
Last Update Posted: August 16, 2018