Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine. (NCT NCT02699099)

Last Updated: 2021-09-29

Results Overview

Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The 95% confidence intervals were calculated using the Analysis of Variance (ANOVA) model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

699 participants

Primary outcome timeframe

At one month post Dose 3 of SB257049 (Month 4)

Results posted on

2021-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Coad Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Overall Study STARTED	231	236	232
Overall Study COMPLETED	223	233	226
Overall Study NOT COMPLETED	8	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Coad Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Overall Study Adverse Event	1	0	2
Overall Study Lost to Follow-up	0	1	0
Overall Study CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT	7	2	4

Baseline Characteristics

Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).	Total n=699 Participants Total of all reporting groups
Age, Continuous	6.3 Months STANDARD_DEVIATION 0.3 • n=5 Participants	6.3 Months STANDARD_DEVIATION 0.3 • n=7 Participants	6.3 Months STANDARD_DEVIATION 0.3 • n=5 Participants	6.3 Months STANDARD_DEVIATION 0.3 • n=4 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	119 Participants n=7 Participants	113 Participants n=5 Participants	348 Participants n=4 Participants
Sex: Female, Male Male	115 Participants n=5 Participants	117 Participants n=7 Participants	119 Participants n=5 Participants	351 Participants n=4 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	231 Participants n=5 Participants	236 Participants n=7 Participants	232 Participants n=5 Participants	699 Participants n=4 Participants

PRIMARY outcome

Timeframe: At one month post Dose 3 of SB257049 (Month 4)

Population: Analysis was performed on the Per-Protocol set for immunogenicity defined for the primary analysis (Month 4.5), which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling outside protocol windows were eliminated.

Outcome measures

Outcome measures
Measure	Coad Group n=207 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=213 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis)	452.87 EU/mL Interval 409.85 to 500.41	422.49 EU/mL Interval 382.89 to 466.18	—

PRIMARY outcome

Timeframe: At one month post Dose 3 of SB257049 (Month 4)

Population: Analysis was performed on the Per-Protocol set for immunogenicity, defined at study end, which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated. One subject that was eliminated at the primary analysis performed at Month 4.5 was included in this analysis.

Concentrations were expressed as GMCs with the following unit of measure: EU/mL. The 95% confidence intervals were calculated using the ANOVA model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. The analysis was re-evaluated and performed on the Per-Protocol set for immunogenicity defined at study end.

Outcome measures

Outcome measures
Measure	Coad Group n=208 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=213 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Anti-CS Antibody Concentrations, One Month Post Dose 3 of SB257049 (Study End Analysis)	454.51 EU/mL Interval 411.43 to 502.11	422.49 EU/mL Interval 382.89 to 466.18	—

SECONDARY outcome

Timeframe: At Day 0 and one month post Dose 3 of SB257049 (Month 4)

Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: ELISA units per milliliter (EU/mL). The 95% CI for the GMC was obtained by exponential transformation (base 10) of the 95% CI for the mean of the log transformed concentrations. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.

Outcome measures

Outcome measures
Measure	Coad Group n=208 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=213 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049 Anti-CS - Day 0	0.96 EU/mL Interval 0.94 to 0.97	0.96 EU/mL Interval 0.94 to 0.98	—
Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049 Anti-CS - Month 4	454.51 EU/mL Interval 408.58 to 505.6	422.49 EU/mL Interval 385.42 to 463.12	—

SECONDARY outcome

Timeframe: At Day 0 and one month post Dose 3 of SB257049 (Month 4)

A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-CS ≥ 1.9 ELISA unit per milliliter \[EU/mL\]). Seropositivity was assessed in the Coad Group and the RTS,S Group.

Outcome measures

Outcome measures
Measure	Coad Group n=208 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=213 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049 Anti-CS - Day 0	1 Participants	2 Participants	—
Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049 Anti-CS - Month 4	207 Participants	213 Participants	—

SECONDARY outcome

Timeframe: At Day 0 and one month post Dose 3 of SB257049 (Month 4)

Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.

Concentrations were expressed as GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-HB was assessed in the Coad Group and the RTS,S Group.

Outcome measures

Outcome measures
Measure	Coad Group n=205 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=210 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049 Anti-HBs - Day 0	397.36 mIU/mL Interval 318.21 to 496.18	427.65 mIU/mL Interval 340.47 to 537.14	—
Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049 Anti-HBs - Month 4	42162.55 mIU/mL Interval 35643.11 to 49874.45	43261.19 mIU/mL Interval 37275.19 to 50208.47	—

SECONDARY outcome

Timeframe: At Day 0 and one month post-Dose 3 of SB257049 (Month 4)

Seroprotection rate for anti-HBs antibody was defined as the percentage of subjects with antibody concentrations greater than or equal to an established cut-off value (anti-HBs ≥ 10 milli-international unit per milliliter \[mIU/mL\]). Seroprotection was assessed in the Coad Group and the RTS,S Group.

Outcome measures

Outcome measures
Measure	Coad Group n=205 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=210 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049 Anti-HB - Day 0	196 Participants	201 Participants	—
Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049 Anti-HB - Month 4	205 Participants	210 Participants	—

SECONDARY outcome

Timeframe: At one month post-vaccination with the combined measles and rubella (MeRu) vaccine (Month 4)

Seroconversion was defined as number of subjects with an anti-Measles antibodies pre-vaccination concentration below 150 mIU/mL and a post-vaccination concentration ≥150 mIU/mL. Seroconversion was assessed in the Coad group and the Control group.

Outcome measures

Outcome measures
Measure	Coad Group n=205 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=216 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine	197 Participants	212 Participants	—

SECONDARY outcome

Timeframe: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)

Concentrations were expressed in GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-Me was assessed in the Coad Group and the Control Group.

Outcome measures

Outcome measures
Measure	Coad Group n=208 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=220 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine Anti-Me - Month 3	75.00 mIU/mL Interval 75.0 to 75.0	75.00 mIU/mL Interval 75.0 to 75.0	—
Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine Anti-Me - Month 4	565.81 mIU/mL Interval 513.4 to 623.57	572.09 mIU/mL Interval 523.83 to 624.79	—

SECONDARY outcome

Timeframe: At pre-vaccination (Month 3) and one month post-vaccination with the combined measles and rubella vaccine (Month 4)

A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Me ≥ 150 mIU/mL). Seropositivity was assessed in the Coad Group and the Control Group.

Outcome measures

Outcome measures
Measure	Coad Group n=208 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=220 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine Anti-Me - Month 3	0 Participants	0 Participants	—
Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine Anti-Me - Month 4	200 Participants	213 Participants	—

SECONDARY outcome

Timeframe: At one month post-vaccination with combined measles and rubella vaccine (Month 4)

Seroconversion was defined as number of subjects with an anti-Ru pre-vaccination concentration less than (\<) 4 IU/mL and a post-vaccination concentration ≥ 4 IU/mL. Seroconversion was assessed in the Coad group and Control group.

Outcome measures

Outcome measures
Measure	Coad Group n=200 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=212 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Seroconverted Subjects for Anti-Rubella (Anti-Ru) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella Vaccine	199 Participants	212 Participants	—

SECONDARY outcome

Timeframe: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)

Concentrations were expressed as GMCs with the following unit of measure: International unit per milliliter (IU/mL). The antibody response of anti-Ru was assessed in the Coad Group and Control Group.

Outcome measures

Outcome measures
Measure	Coad Group n=208 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=220 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine Anti-Ru - Month 3	2.08 IU/mL Interval 1.99 to 2.18	2.09 IU/mL Interval 1.98 to 2.2	—
Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine Anti-Ru - Month 4	39.36 IU/mL Interval 35.2 to 44.01	42.45 IU/mL Interval 38.42 to 46.92	—

SECONDARY outcome

Timeframe: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)

A subject seropositive for anti-Ru antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Ru ≥ 4 IU/mL). Seropositivity was assessed in the Coad Group and Control Group.

Outcome measures

Outcome measures
Measure	Coad Group n=208 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=220 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine Anti-Ru - Month 3	5 Participants	4 Participants	—
Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine Anti-Ru - Month 4	207 Participants	217 Participants	—

SECONDARY outcome

Timeframe: At one month post-vaccination with the YF vaccine (Month 4)

Seropositivity was defined as number of subjects with anti-YF titers greater than or equal to (≥) 10 End point Dilution 50 (ED50). Seropositivity was assessed in the Coad group and Control group.

Outcome measures

Outcome measures
Measure	Coad Group n=207 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=217 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Seropositive Subjects for Anti-Yellow Fever (Anti-YF) Antibodies, at One Month Post-vaccination With the YF Vaccine	203 Participants	214 Participants	—

SECONDARY outcome

Timeframe: At one month post-vaccination with the YF vaccine (Month 4)

Titers were expressed as Geometric Mean Titres (GMTs). The antibody response of anti-YF was assessed in the Coad Group and Control Group.

Outcome measures

Outcome measures
Measure	Coad Group n=207 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=217 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Anti-YF Antibody Titers One Month Post-vaccination With the YF Vaccine	324.31 Titers Interval 273.54 to 384.51	346.60 Titers Interval 296.73 to 404.86	—

SECONDARY outcome

Timeframe: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0)

Population: Analysis was performed on the Exposed set which included all subjects with the first dose of SB257049 and Vitamin A administered (Coad and RTS,S Groups).

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Redness - Grade 3	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Pain - Any	25 Participants	16 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Pain - Grade 3	0 Participants	1 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Redness - Any	7 Participants	13 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Swelling - Any	8 Participants	6 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Swelling - Grade 3	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0)

Population: Analysis was performed on the Exposed set which included all subjects with the first dose of SB257049 and Vitamin A administered (Coad and RTS,S Groups).

Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=235 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Loss of appetite - Grade 3	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Measles/Rubella-like rash - Grade 3 related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Drowsiness - Any	4 Participants	4 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Drowsiness - Grade 3	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Drowsiness - Related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Drowsiness - Grade 3 related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Irritability/Fussiness - Any	14 Participants	22 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Irritability/Fussiness - Grade 3	1 Participants	1 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Irritability/Fussiness - Related	2 Participants	1 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Irritability/Fussiness - Grade 3 related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Loss of appetite - Any	5 Participants	7 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Loss of appetite - Related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Loss of appetite - Grade 3 related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Measles/Rubella-like rash - Any	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Measles/Rubella-like rash - Grade 3	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Measles/Rubella-like rash - Related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Fever - Any	32 Participants	30 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Fever - Grade 3	3 Participants	1 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Fever - Related	10 Participants	8 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age Fever - Grade 3 related	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A (Day 0)

Population: Analysis was performed on the Exposed set which included all subjects with Vitamin A administered (Control group). In the Control Group, only solicited general symptoms were collected.

Outcome measures

Outcome measures
Measure	Coad Group n=232 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Drowsiness - Related	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Loss of appetite- Grade 3	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Drowsiness - Any	1 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Drowsiness - Grade 3	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Drowsiness - Grade 3 related	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Irritability/Fussiness - Any	6 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Irritability/Fussiness - Grade 3	1 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Irritability/Fussiness - Related	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Irritability/Fussiness - Grade 3 related	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Loss of appetite - Any	9 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Loss of appetite- Related	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Loss of appetite- Grade 3 related	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Measles/Rubella-like rash - Any	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Measles/Rubella-like rash - Grade 3	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Measles/Rubella-like rash - Related	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Measles/Rubella-like rash - Grade 3 related	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Fever - Any	11 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Fever - Grade 3	0 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Fever - Related	1 Participants	—	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age Fever - Grade 3 related	0 Participants	—	—

SECONDARY outcome

Timeframe: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5)

Population: Analysis was performed on the Exposed set which included all subjects with the second dose of SB257049 administered (Coad and RTS,S Groups).

Outcome measures

Outcome measures
Measure	Coad Group n=224 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=234 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Pain - Any	3 Participants	12 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Pain - Grade 3	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Redness - Any	4 Participants	2 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Redness - Grade 3	1 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Swelling - Any	4 Participants	6 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Swelling - Grade 3	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5)

Population: Analysis was performed on the Exposed set which included all subjects with the second dose of SB257049 administered (Coad and RTS,S Groups).

Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	Coad Group n=224 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=234 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Irritability/Fussiness - Grade 3	0 Participants	1 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Irritability/Fussiness - Grade 3 related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Drowsiness - Any	6 Participants	5 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Drowsiness - Grade 3	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Drowsiness - Related	1 Participants	2 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Drowsiness - Grade 3 related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Irritability/Fussiness - Any	11 Participants	13 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Irritability/Fussiness - Related	4 Participants	2 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Loss of appetite - Any	6 Participants	11 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Loss of appetite - Grade 3	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Loss of appetite - Related	1 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Loss of appetite - Grade 3 related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Measles/Rubella-like rash - Any	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Measles/Rubella-like rash - Grade 3	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Measles/Rubella-like rash - Related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Measles/Rubella-like rash - Grade 3 related	0 Participants	0 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Fever - Any	47 Participants	47 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Fever - Grade 3	3 Participants	3 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Fever - Related	11 Participants	9 Participants	—
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age Fever - Grade 3 related	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: After visit at Month 1.5

Population: Analysis was not performed. Solicited symptoms were not collected for the Control group after visit at Month 1.5 because no vaccination was administered.

Solicited symptoms were not analyzed for the Control Group after visit at Month 1.5 because no vaccination was administered at that visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3)

Population: Analysis was performed on the Exposed set which included all subjects with SB257049 dose 3 for Coad (and MeRu+YF vaccines) and RTS,S Groups, and MeRU+YF vaccines for Control Group.

Outcome measures

Outcome measures
Measure	Coad Group n=221 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=228 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=225 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Pain - Any	10 Participants	10 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Pain - Grade 3	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Redness - Any	0 Participants	1 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Redness - Grade 3	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Swelling - Any	3 Participants	3 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Swelling - Grade 3	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Population: Analysis was performed on the Exposed set which included all subjects with SB257049 dose 3 for Coad (and MeRu + YF vaccines) and RTS,S Groups, and MeRU+YF vaccines for Control Group.

Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	Coad Group n=221 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=229 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=225 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Loss of appetite - Any	8 Participants	6 Participants	2 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Fever - Any	54 Participants	50 Participants	17 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Drowsiness - Any	7 Participants	6 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Drowsiness - Grade 3	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Drowsiness - Related	4 Participants	5 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Drowsiness - Grade 3 related	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Irritability/Fussiness - Any	11 Participants	8 Participants	1 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Irritability/Fussiness - Grade 3	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Irritability/Fussiness - Related	4 Participants	4 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Irritability/Fussiness - Grade 3 related	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Loss of appetite - Grade 3	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Loss of appetite - Related	2 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Loss of appetite - Grade 3 related	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Measles/Rubella-like rash - Any	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Measles/Rubella-like rash - Grade 3	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Measles/Rubella-like rash - Related	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Measles/Rubella-like rash - Grade 3 related	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Fever - Grade 3	3 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Fever - Related	26 Participants	23 Participants	8 Participants
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age Fever - Grade 3 related	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 30-day (Days 0-29) period after dose 1 of SB257049 and Vitamin A- Coad and RTS,S Groups, and 30-day period after Vitamin A administration - Control Group

Population: Analysis was performed on the Exposed set which included all subjects with first dose of the study vaccine + Vitamin A (Coad and RTS,S Groups) or Vitamin A (Control Group).

An unsolicited adverse event is any adverse event (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.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age	116 Participants	119 Participants	111 Participants

SECONDARY outcome

Timeframe: Within 30-day (Day of vaccination and 29 subsequent days) period after dose 2 of SB257049 administered at Month 1.5 - Coad and RTS,S Groups

Population: Analysis was performed on the Exposed set which included all subjects with the second dose of the study vaccine administered (Coad and RTS,S Groups).

Outcome measures

Outcome measures
Measure	Coad Group n=225 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=234 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After Dose of Study Vaccines at 7.5 Months of Age	107 Participants	109 Participants	—

SECONDARY outcome

Timeframe: During the 30-day period (Day of the visit and 29 subsequent days) after the visit at Month 1.5

Population: Analysis was performed on the Exposed set which included all subjects from the Control Group who completed the visit at Month 1.5.

Outcome measures

Outcome measures
Measure	Coad Group n=229 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Unsolicited AEs for the Control Group, at Visit at 7.5 Months of Age	80 Participants	—	—

SECONDARY outcome

Timeframe: Within 42-day (vaccination day and 41 subsequent days) period after dose 3 of SB257049 in Coad (+MeRu+YF vaccines) and RTS,S groups, and 42-day period after MeRU+YF vaccination in Control group, administered at Month 3

Population: Analysis was performed on the Exposed set which included all subjects with the third dose of the study vaccine for Coad (+MeRu+YF vacines) and RTS,S Groups, or MeRU + YF vaccine for the Control Group.

Outcome measures

Outcome measures
Measure	Coad Group n=222 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=227 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age	120 Participants	121 Participants	125 Participants

SECONDARY outcome

Timeframe: During 30-Days period (Day of vaccination and 29 subsequent days) following each administration at Day 0, Month1.5 and Month 3 for Coad and RTS,S groups and at Day 0 and Month 3 in the Control Group.

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 Any SAEs	13 Participants	8 Participants	16 Participants
Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 Fatal SAEs	1 Participants	0 Participants	1 Participants
Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 Related SAEs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 4.5

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccines or Vitamin A administered.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5	14 Participants	12 Participants	21 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 4.5

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 4.5

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 30 days post-vaccination for vaccine doses administered at Day 0, Month 1.5 or 42 days post-vaccination (doses given at Month 3 [Coad & Control Groups] or Month 4.5 [RTS,S Group]) vaccination period from Day 0 until Month 4.5

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 7 days after vaccines administered at Day 0 and Month 1.5 for the Coad and RTS,S groups and 14 days after vaccines administered at Month 3 for all groups

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 30-day period (Day of vaccination and 29 subsequent days) after booster dose administered at Month 21

Population: Analysis was performed on the Exposed set which included all subjects with the booster dose of study vaccine administered at 27 months of age (Coad and RTS,S Groups)

Outcome measures

Outcome measures
Measure	Coad Group n=216 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=209 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After the Booster Dose of Study Vaccine Administered at 27 Months of Age	62 Participants	67 Participants	—

SECONDARY outcome

Timeframe: During the 30-Day Period (Day of vaccination and 29 subsequent days) after primary doses of study vaccine administered at Month 4.5, Month 5.5, Month 6.5 (across primary doses), and after booster dose administered at Month 24

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of study vaccine administered at 10.5, 11.5, 12.5 and 30 months of age (Control Group).

Outcome measures

Outcome measures
Measure	Coad Group n=223 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Unsolicited AEs for the Control Group, After Dose of Study Vaccine Administered at 10.5, 11.5, 12.5 and 30 Months of Age Across primary doses	160 Participants	—	—
Number of Subjects With Unsolicited AEs for the Control Group, After Dose of Study Vaccine Administered at 10.5, 11.5, 12.5 and 30 Months of Age At Month 24	57 Participants	—	—

SECONDARY outcome

Timeframe: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End	61 Participants	62 Participants	66 Participants

SECONDARY outcome

Timeframe: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group n=232 Participants Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 30 days post-vaccination (doses given at Day 0, Month 1.5, Month 21) & 42 days post-vaccination (dose given at Month 3 [Coad Group] or Month 4.5 [RTS,S Group])

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for Coad and RTS,S Groups.

Outcome measures

Outcome measures
Measure	Coad Group n=231 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group n=236 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Seizures for Vaccines Doses Administered at 6, 7.5, 27 Months of Age for Coad and RTS,S Groups; and at 9 Months of Age for Coad Group or 10.5 Months of Age for RTS,S Group	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within 30 days post-vaccination (doses given at Month 4.5, Month 5.5, Month 6.5, Month 24) & 42 days post-vaccination (dose given at Month 3)

Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.

Outcome measures

Outcome measures
Measure	Coad Group n=232 Participants Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	RTS,S Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).	Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).
Number of Subjects With Seizures for Vaccines Doses Administered at 10.5, 11.5, 12.5, 30 and 9 Months of Age for Control Group	1 Participants	—	—

Adverse Events

Coad Group

Serious events: 61 serious events

Other events: 219 other events

Deaths: 2 deaths

RTS,S Group

Serious events: 62 serious events

Other events: 221 other events

Deaths: 0 deaths

Control Group

Serious events: 66 serious events

Other events: 207 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER