Trial Outcomes & Findings for Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa (NCT NCT00866619)

Last Updated: 2019-10-09

Results Overview

A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia was greater than (\>) 5000 parasites per microliter (µL) accompanied by the presence of fever \[axillary temperature greater than or equal to (≥) 37.5°C\] at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 5-17 months age category.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

15459 participants

Primary outcome timeframe

From Month 2.5 to Month 14

Results posted on

2019-10-09

Participant Flow

The study included 3 phases, a primary (PRI) phase (Months 0-3) and a booster (BST) phase at Month 20, each followed by a related PRI/BST efficacy, immunogenicity and safety (EIS) follow-up (FU) phase, and an EIS extension, from Month 32 to the median of Month 48 or Month 38 time point.

Screening included the following: check for inclusion/exclusion criteria, vaccination contraindications/precautions, subjects' medical history and signing informed consent forms.

Participant milestones

Participant milestones
Measure	GSK257049 [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Study STARTED	5948	4358	2974	2179
Overall Study COMPLETED	4102	3088	2085	1549
Overall Study NOT COMPLETED	1846	1270	889	630

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK257049 [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Overall Study Adverse Event	112	106	47	44
Overall Study Protocol Violation	2	39	2	17
Overall Study Withdrawal by Subject	587	295	272	144
Overall Study Lost to Follow-up	1145	830	568	425

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK257049 [5-17M] Group n=5948 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 [6-12W] Group n=4358 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	VeroRab Comparator [5-17M] Group n=2974 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Total n=15459 Participants Total of all reporting groups
Age, Continuous	10.6 Months STANDARD_DEVIATION 3.8 • n=5 Participants	1.2 Months STANDARD_DEVIATION 0.4 • n=7 Participants	10.6 Months STANDARD_DEVIATION 3.7 • n=5 Participants	1.2 Months STANDARD_DEVIATION 0.4 • n=4 Participants	6.6 Months STANDARD_DEVIATION 5.5 • n=21 Participants
Sex: Female, Male Female	2967 Participants n=5 Participants	2124 Participants n=7 Participants	1503 Participants n=5 Participants	1100 Participants n=4 Participants	7694 Participants n=21 Participants
Sex: Female, Male Male	2981 Participants n=5 Participants	2234 Participants n=7 Participants	1471 Participants n=5 Participants	1079 Participants n=4 Participants	7765 Participants n=21 Participants
Race/Ethnicity, Customized African heritage/African American	5948 Participants n=5 Participants	4358 Participants n=7 Participants	2974 Participants n=5 Participants	2179 Participants n=4 Participants	15459 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Month 2.5 to Month 14

Population: The analysis was performed on the According-to-Protocol (ATP) population for efficacy, which included all children aged 5-17 Months who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2830 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1466 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of First or Only Clinical Episode of Plasmodium Falciparum (P. Falciparum) Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD)	0.435 events per person-year	0.833 events per person-year	—	—	—	—

PRIMARY outcome

Timeframe: From Month 2.5 to Month 14

Population: The analysis was performed on the ATP population for efficacy, which included all children aged 6-12 Weeks who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.

A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia \> 5000 parasites/µL was accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is, person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 6-12 weeks (6-12W) age category.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=3995 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2008 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD)	0.367 events per person-year	0.484 events per person-year	—	—	—	—

SECONDARY outcome

Timeframe: From Month 2.5 to Month 14

Population: The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.

PCD=malaria episode with P. falciparum asexual parasitemia (PFAP) \> 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease. SCD1=malaria episode with PFAP \> 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2=malaria episode with PFAP \> 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3=malaria episode with PFAP \> 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2830 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3995 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1466 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2008 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of P. Falciparum Clinical Malaria Infection (CPFMI) of PCD and of Secondary Case Definitions (SCD) 1, SCD 2 and SCD 3 PCD	0.735 events per person-year	0.639 events per person-year	1.468 events per person-year	—	0.908 events per person-year	—
Rate of All Episodes of P. Falciparum Clinical Malaria Infection (CPFMI) of PCD and of Secondary Case Definitions (SCD) 1, SCD 2 and SCD 3 SCD1	1.224 events per person-year	0.989 events per person-year	2.312 events per person-year	—	1.403 events per person-year	—
Rate of All Episodes of P. Falciparum Clinical Malaria Infection (CPFMI) of PCD and of Secondary Case Definitions (SCD) 1, SCD 2 and SCD 3 SCD2	0.847 events per person-year	0.736 events per person-year	1.628 events per person-year	—	1.031 events per person-year	—
Rate of All Episodes of P. Falciparum Clinical Malaria Infection (CPFMI) of PCD and of Secondary Case Definitions (SCD) 1, SCD 2 and SCD 3 SCD3	0.625 events per person-year	0.515 events per person-year	1.244 events per person-year	—	0.731 events per person-year	—

SECONDARY outcome

Timeframe: From Month 2.5 to Month 20

PCD = malaria episode with PFAP \> 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease (see below endpoints on severe malaria for details). Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are by center and across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=4557 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3996 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2328 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Agogo	0.56 events per person-year	0.64 events per person-year	1.16 events per person-year	—	0.79 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Bagamoyo	0.1 events per person-year	0.08 events per person-year	0.28 events per person-year	—	0.14 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Kilifi	0.01 events per person-year	0.04 events per person-year	0.04 events per person-year	—	0.02 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Kintampo	1.01 events per person-year	1.53 events per person-year	1.85 events per person-year	—	1.49 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Kombewa	1.21 events per person-year	0.94 events per person-year	1.87 events per person-year	—	1.32 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Korogwe	0.04 events per person-year	0.03 events per person-year	0.11 events per person-year	—	0.05 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Lambarene	0.11 events per person-year	0.11 events per person-year	0.2 events per person-year	—	0.12 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Lilongwe	0.2 events per person-year	0.3 events per person-year	0.32 events per person-year	—	0.5 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Manhica	—	0.1 events per person-year	—	—	0.12 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Nanoro	1.42 events per person-year	1.93 events per person-year	2.4 events per person-year	—	2.39 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Siaya	2.01 events per person-year	2.03 events per person-year	3.31 events per person-year	—	2.75 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center PCD - Across	0.69 events per person-year	0.71 events per person-year	1.17 events per person-year	—	0.92 events per person-year	—

SECONDARY outcome

Timeframe: From Month 2.5 to Month 20

SCD1 = malaria episode with PFAP \> 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2 = malaria episode with PFAP \> 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3 = malaria episode with PFAP \> 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=4557 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3996 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2328 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of SCD1, SCD2 and SCD3 (Overall) SCD1	1.09 events per person-year	1.09 events per person-year	1.78 events per person-year	—	1.42 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of SCD1, SCD2 and SCD3 (Overall) SCD2	0.78 events per person-year	0.81 events per person-year	1.3 events per person-year	—	1.04 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of SCD1, SCD2 and SCD3 (Overall) SCD3	0.59 events per person-year	0.58 events per person-year	1.01 events per person-year	—	0.76 events per person-year	—

SECONDARY outcome

Timeframe: From Month 2.5 up to study End (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Kilifi	0.02 events per person-year	0.03 events per person-year	0.08 events per person-year	0.04 events per person-year	0.06 events per person-year	0.04 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Korogwe	0.04 events per person-year	0.05 events per person-year	0.1 events per person-year	0.07 events per person-year	0.05 events per person-year	0.09 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Lambarene	0.15 events per person-year	0.15 events per person-year	0.23 events per person-year	0.18 events per person-year	0.1 events per person-year	0.17 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Bagamoyo	0.16 events per person-year	0.21 events per person-year	0.27 events per person-year	0.11 events per person-year	0.08 events per person-year	0.15 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Lilongwe	0.09 events per person-year	0.2 events per person-year	0.23 events per person-year	0.29 events per person-year	0.25 events per person-year	0.42 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Agogo	0.59 events per person-year	0.73 events per person-year	1.01 events per person-year	0.77 events per person-year	0.59 events per person-year	0.84 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Kombewa	1.26 events per person-year	1.37 events per person-year	1.64 events per person-year	1.37 events per person-year	1.37 events per person-year	1.62 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Kintampo	1.11 events per person-year	1.31 events per person-year	1.71 events per person-year	1.71 events per person-year	1.65 events per person-year	1.69 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Manhica	—	—	—	0.14 events per person-year	0.18 events per person-year	0.2 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Nanoro	1.95 events per person-year	2.18 events per person-year	2.69 events per person-year	2.79 events per person-year	2.59 events per person-year	3.14 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Siaya	2.09 events per person-year	2.55 events per person-year	3.15 events per person-year	2.67 events per person-year	2.43 events per person-year	3.12 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers PCD - Across	0.79 events per person-year	0.9 events per person-year	1.14 events per person-year	0.95 events per person-year	0.86 events per person-year	1.08 events per person-year

SECONDARY outcome

Timeframe: From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

CPFMI of SCD1 = malaria episode with PFAP \>0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1), Across Centers	1.26 events per person-year	1.41 events per person-year	1.81 events per person-year	1.43 events per person-year	1.29 events per person-year	1.61 events per person-year

SECONDARY outcome

Timeframe: From Booster at Month 20 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

CPFMI of PCD = episode of malaria for which PFAP \> 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP \>0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2017 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2057 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2050 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1788 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1743 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1762 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), Across Centers PCD	0.87 events per person-year	1.03 events per person-year	1.1 events per person-year	1.21 events per person-year	1.01 events per person-year	1.23 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), Across Centers SCD1	1.39 events per person-year	1.65 events per person-year	1.82 events per person-year	1.79 events per person-year	1.48 events per person-year	1.8 events per person-year

SECONDARY outcome

Timeframe: From Month 33 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

CPFMI of PCD = episode of malaria for which PFAP \> 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP \> 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=1784 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1838 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1864 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1548 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1516 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1546 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD and SCD1, Across Centers SCD1	1.61 events per person-year	1.79 events per person-year	1.88 events per person-year	1.92 events per person-year	1.73 events per person-year	1.91 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD and SCD1, Across Centers PCD	1.01 events per person-year	1.1 events per person-year	1.1 events per person-year	1.31 events per person-year	1.18 events per person-year	1.29 events per person-year

SECONDARY outcome

Timeframe: From Month 2.5 to Month 32

CPFMI of PCD = episode of malaria for which PFAP \> 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Nanoro	1.42 events per person-year	1.67 events per person-year	2.45 events per person-year	2.53 events per person-year	2.27 events per person-year	2.92 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Siaya	1.91 events per person-year	2.46 events per person-year	3.25 events per person-year	2.54 events per person-year	2.41 events per person-year	3.09 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Across	0.68 events per person-year	0.81 events per person-year	1.15 events per person-year	0.88 events per person-year	0.8 events per person-year	1.03 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Kilifi	0.03 events per person-year	0.04 events per person-year	0.09 events per person-year	0.04 events per person-year	0.06 events per person-year	0.05 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Korogwe	0.04 events per person-year	0.03 events per person-year	0.08 events per person-year	0.06 events per person-year	0.02 events per person-year	0.06 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Lambarene	0.14 events per person-year	0.14 events per person-year	0.21 events per person-year	0.18 events per person-year	0.1 events per person-year	0.18 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Bagamoyo	0.13 events per person-year	0.19 events per person-year	0.31 events per person-year	0.11 events per person-year	0.08 events per person-year	0.15 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Lilongwe	0.11 events per person-year	0.22 events per person-year	0.29 events per person-year	0.32 events per person-year	0.27 events per person-year	0.47 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Agogo	0.59 events per person-year	0.75 events per person-year	1.15 events per person-year	0.72 events per person-year	0.56 events per person-year	0.86 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Kombewa	1.12 events per person-year	1.29 events per person-year	1.67 events per person-year	1.25 events per person-year	1.28 events per person-year	1.55 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Kintampo	1.08 events per person-year	1.17 events per person-year	1.87 events per person-year	1.6 events per person-year	1.52 events per person-year	1.6 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers PCD - Manhica	—	—	—	0.12 events per person-year	0.15 events per person-year	0.15 events per person-year

SECONDARY outcome

Timeframe: From Month 2.5 to Month 32

CPFMI of SCD1 = malaria episode with PFAP \> 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1)	1.1 events per person-year	1.24 events per person-year	1.78 events per person-year	1.33 events per person-year	1.19 events per person-year	1.54 events per person-year

SECONDARY outcome

Timeframe: From Booster at Month 20 up to Month 32

CPFMI of PCD = episode of malaria for which PFAP \> 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP \> 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2017 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2057 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2050 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1788 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1743 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1762 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1) SCD1	1.14 events per person-year	1.48 events per person-year	1.74 events per person-year	1.72 events per person-year	1.35 events per person-year	1.74 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1) PCD	0.72 events per person-year	0.96 events per person-year	1.1 events per person-year	1.15 events per person-year	0.91 events per person-year	1.2 events per person-year

SECONDARY outcome

Timeframe: From Month 2.5 up to the time when 250 subjects were diagnosed with severe malaria of PCD, SCD1, SCD2 and SCD3 (up to the Month 14 time point for each age category or date of booster dose, whichever occurred first)

Population: The analysis was performed, across age categories for which groups were pooled from the ATP population for efficacy. This included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3.

SPFMI of PCD = PFMI \> 5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI \>5000 parasites/μL and with one or more severity marker. SPFMI of SCD2 = PFMI \>0 with one or more severity marker and without co-morbidity diagnosis. SPFMI of SCD3 = PFMI \>5000 parasites/μL, with one or more severity marker, and without co-morbidity or HIV. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia \< 2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l \< 5.0 mmol/L; anaemia\<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. Analysis was performed in a pooled manner across age categories. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=8597 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=4364 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, Across Centers SCD1	0.023 Percentage of subjects	0.036 Percentage of subjects	—	—	—	—
Percentage of Subjects With Severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, Across Centers PCD	0.019 Percentage of subjects	0.03 Percentage of subjects	—	—	—	—
Percentage of Subjects With Severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, Across Centers SCD2	0.023 Percentage of subjects	0.034 Percentage of subjects	—	—	—	—
Percentage of Subjects With Severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, Across Centers SCD3	0.019 Percentage of subjects	0.03 Percentage of subjects	—	—	—	—

SECONDARY outcome

Timeframe: From Month 2.5 to Month 14

SPFMI of PCD = PFMI\>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI\>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia\<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia\<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI\>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia\<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia\<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2830 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3995 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1466 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2008 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SPFMI PCD	2.0 Percentage of subjects	1.5 Percentage of subjects	3.8 Percentage of subjects	—	2.3 Percentage of subjects	—
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SPFMI SCD1	2.6 Percentage of subjects	1.6 Percentage of subjects	4.9 Percentage of subjects	—	2.5 Percentage of subjects	—

SECONDARY outcome

Timeframe: From Month 2.5 to Month 20 at Booster

SPFMI of PCD = PFMI\>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI\>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia\<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia\<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI\>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia\<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia\<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=4557 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3996 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2328 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SPFMI PCD	0.03 Percentage of subjects	0.03 Percentage of subjects	0.04 Percentage of subjects	—	0.03 Percentage of subjects	—
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SPFMI SCD1	0.03 Percentage of subjects	0.03 Percentage of subjects	0.05 Percentage of subjects	—	0.03 Percentage of subjects	—

SECONDARY outcome

Timeframe: From Month 2.5, from Month 20(booster), from Month 33 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17M age category and of 38 months post-Dose 1 for 6-12W age category) and from Month 2.5 to Month 32 and from Month 20 to Month 32

SPFMI of PCD = PFMI \>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI \>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia\<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia\<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI \>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia\<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia\<5.0 g/dL.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 PCD, M2.5 to SE	0.04 Percentage of subjects	0.06 Percentage of subjects	0.06 Percentage of subjects	0.04 Percentage of subjects	0.04 Percentage of subjects	0.05 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 PCD, M20 to SE	0.03 Percentage of subjects	0.04 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 PCD, M2.5 to M32	0.03 Percentage of subjects	0.05 Percentage of subjects	0.05 Percentage of subjects	0.04 Percentage of subjects	0.04 Percentage of subjects	0.04 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SCD1, M2.5 to SE	0.05 Percentage of subjects	0.07 Percentage of subjects	0.07 Percentage of subjects	0.05 Percentage of subjects	0.04 Percentage of subjects	0.06 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 PCD, M33 to SE	0.01 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 PCD, M20 to M32	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SCD1, M20 to SE	0.03 Percentage of subjects	0.04 Percentage of subjects	0.03 Percentage of subjects	0.03 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SCD1, M33 to SE	0.01 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SCD1, M2.5 to M32	0.04 Percentage of subjects	0.06 Percentage of subjects	0.06 Percentage of subjects	0.04 Percentage of subjects	0.04 Percentage of subjects	0.05 Percentage of subjects
Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 SCD1, M20 to M32	0.02 Percentage of subjects	0.03 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects

SECONDARY outcome

Timeframe: From Month 2.5 to Month 20

CD considered were CD1 for ISA and CD1 and CD2 for MH. ISA of CD1 was defined as a documented hemoglobin \< 5.0 g/dL identified at clinical presentation to morbidity surveillance system in association with a P. falciparum parasitemia \> 5000 parasites/μL. MH of CD1 was defined as a medical hospitalization with confirmed P. falciparum \> 5000 parasites/μL. MH of CD2 was defined as a hospitalization which, in the judgment of the principal investigator, P. falciparum infection was the sole or a major contributing factor to the presentation. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=4557 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3996 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2328 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Incident Severe Anaemia (ISA) and Malaria Hospitalization (MH) for Case Definitions (CD) Considered ISA CD1	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	—	0.01 Percentage of subjects	—
Percentage of Subjects With Incident Severe Anaemia (ISA) and Malaria Hospitalization (MH) for Case Definitions (CD) Considered MH CD1	0.05 Percentage of subjects	0.04 Percentage of subjects	0.09 Percentage of subjects	—	0.05 Percentage of subjects	—
Percentage of Subjects With Incident Severe Anaemia (ISA) and Malaria Hospitalization (MH) for Case Definitions (CD) Considered MH CD2	0.06 Percentage of subjects	0.05 Percentage of subjects	0.1 Percentage of subjects	—	0.06 Percentage of subjects	—

SECONDARY outcome

Timeframe: From Month 2.5 to up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered ISA CD1	0.01 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered ISA CD2	0.01 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered ISA CD3	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered MH CD1	0.07 Percentage of subjects	0.1 Percentage of subjects	0.12 Percentage of subjects	0.07 Percentage of subjects	0.06 Percentage of subjects	0.08 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered MH CD2	0.09 Percentage of subjects	0.11 Percentage of subjects	0.13 Percentage of subjects	0.09 Percentage of subjects	0.08 Percentage of subjects	0.1 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered FM PCD	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered FM SCD1	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered FM SCD4	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0.01 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects

SECONDARY outcome

Timeframe: From Month 2.5 to Month 32

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered ISA CD3	0.01 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered MH CD2	0.08 Percentage of subjects	0.1 Percentage of subjects	0.12 Percentage of subjects	0.08 Percentage of subjects	0.07 Percentage of subjects	0.09 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered FM PCD	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered MH CD1	0.06 Percentage of subjects	0.09 Percentage of subjects	0.11 Percentage of subjects	0.06 Percentage of subjects	0.05 Percentage of subjects	0.07 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered FM SCD1	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered FM SCD4	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered ISA CD1	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.1 Percentage of subjects	0.01 Percentage of subjects
Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered ISA CD2	0.01 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects

SECONDARY outcome

Timeframe: At Month 20 (Booster)

Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density \> 0 identified at timing of assessment. Prevalent gametocytemia (PG) was defined as a documented P. falciparum gametocyte density \> 0 identified at a cross sectional survey. Prevalent severe anemia (PSA) was defined as a documented hemoglobin \< 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin \< 8.0 g/dL identified at at timing of assessment. Results presented are uncorrected for the double enrollment of one subject receiving RTS,S/AS01.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=4140 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3571 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2100 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1766 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Prevalent Parasitemia, Prevalent Gametocytemia and Prevalent Severe and Moderate Anemia PG	0.03 Percentage of subjects	—	0.04 Percentage of subjects	—	—	—
Percentage of Subjects With Prevalent Parasitemia, Prevalent Gametocytemia and Prevalent Severe and Moderate Anemia PP	0.07 Percentage of subjects	0.07 Percentage of subjects	0.11 Percentage of subjects	—	0.08 Percentage of subjects	—
Percentage of Subjects With Prevalent Parasitemia, Prevalent Gametocytemia and Prevalent Severe and Moderate Anemia PSA	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	0 Percentage of subjects	—
Percentage of Subjects With Prevalent Parasitemia, Prevalent Gametocytemia and Prevalent Severe and Moderate Anemia PMA	0.03 Percentage of subjects	0.04 Percentage of subjects	0.03 Percentage of subjects	—	0.04 Percentage of subjects	—

SECONDARY outcome

Timeframe: At Months 32, 44, at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category) (early and late)

Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density \> 0 identified at timing of assessment. Prevalent severe anemia (PSA) was defined as a documented hemoglobin \< 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin \< 8.0 g/dL identified at timing of assessment. Analysis was performed on subjects aged 5-17 months at enrollment. Study End (Early) corresponds to children whose Month 32 visit took place after 30 June 2012 and who had one cross-sectional visit at study end. These children's last study visit was relatively earlier, with a median follow-up time of 14 months post Month 32. Study End (Late) corresponds to children whose Month 32 visit took place before (and including) 30 June 2012, and who had 2 cross-sectional visits after Month 32. These children's last study visit was relatively later, with a median follow-up time of 17 months post Month 32).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=1935 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1967 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1979 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1656 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1637 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1648 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PP, Month 32	0.09 Percentage of subjects	0.1 Percentage of subjects	0.14 Percentage of subjects	0.11 Percentage of subjects	0.09 Percentage of subjects	0.1 Percentage of subjects
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PSA, Month 32	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PMA, Month 32	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.04 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PP, Month 44	0.16 Percentage of subjects	0.17 Percentage of subjects	0.2 Percentage of subjects	—	—	—
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PSA, Month 44	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	—	—
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PMA, Month 44	0.01 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	—	—	—
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PP, SE (Early)	0.09 Percentage of subjects	0.1 Percentage of subjects	0.14 Percentage of subjects	0.14 Percentage of subjects	0.11 Percentage of subjects	0.13 Percentage of subjects
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PSA, SE (Early)	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PMA, SE (Early)	0.01 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects	0.03 Percentage of subjects	0.03 Percentage of subjects	0.03 Percentage of subjects
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PP, SE (Late)	0.18 Percentage of subjects	0.18 Percentage of subjects	0.21 Percentage of subjects	—	—	—
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PSA, SE (Late)	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	—	—
Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia PMA, SE (Late)	0.03 Percentage of subjects	0.03 Percentage of subjects	0.02 Percentage of subjects	—	—	—

SECONDARY outcome

Timeframe: From Month 2.5 to Month 20

Pneumonia case definitions assessed are PCD and SCD 1, 2 and 3. Pneumonia of PCD was defined as cough or difficulty breathing AND tachypnea (≥ 50 breaths per minute \< 1 year, ≥ 40 breaths per minute ≥ 1year) AND lower chest wall indrawing. Pneumonia of SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission. Pneumonia of SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission. Pneumonia of SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation \< 90%. All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excludes planned admissions for medical investigation/care or elective surgery and trauma). Sepsis cases were defined as a child with positive blood culture (CD1) or salmonella blood culture (CD2).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=4557 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3996 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2328 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed Pneumonia PCD	0.03 Percentage of subjects	0.04 Percentage of subjects	0.03 Percentage of subjects	—	0.04 Percentage of subjects	—
Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed Pneumonia SCD1	0.01 Percentage of subjects	0.01 Percentage of subjects	0 Percentage of subjects	—	0.01 Percentage of subjects	—
Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed Pneumonia SCD2	0.02 Percentage of subjects	0.03 Percentage of subjects	0.02 Percentage of subjects	—	0.03 Percentage of subjects	—
Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed Pneumonia SCD3	0 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	—	0.01 Percentage of subjects	—
Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed All-Cause Hospitalization PCD	0.15 Percentage of subjects	0.18 Percentage of subjects	0.19 Percentage of subjects	—	0.19 Percentage of subjects	—
Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed Sepsis CD1	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	—	0.01 Percentage of subjects	—
Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed Sepsis CD2	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	—	0.01 Percentage of subjects	—

SECONDARY outcome

Timeframe: From Month 2.5 to Month 20

Fatal malaria case definitions assessed were PCD and SCD1. Fatal malaria of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease (defined in a previous outcome measure) with a fatal outcome. Fatal malaria of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease (defined previously) with a fatal outcome. All-cause mortality case definitions assessed were the case definitions (CD) 1 and 2. All-cause mortality of CD1 was defined as a fatality (of any cause) (including mortality in the community and in hospital). All-cause mortality of CD2 was defined as a fatality (medical cause) (including mortality in the community and in hospital), at the exclusion of trauma which may be diagnosed by verbal autopsy. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=4557 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=3996 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2328 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Fatal Malaria (FM) and All-cause Mortality (ACM) as Per Case Definitions Assessed Fatal Malaria PCD	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	0 Percentage of subjects	—
Percentage of Subjects With Fatal Malaria (FM) and All-cause Mortality (ACM) as Per Case Definitions Assessed Fatal Malaria SCD1	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	0 Percentage of subjects	—
Percentage of Subjects With Fatal Malaria (FM) and All-cause Mortality (ACM) as Per Case Definitions Assessed All-cause mortality CD1	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	—	0.01 Percentage of subjects	—
Percentage of Subjects With Fatal Malaria (FM) and All-cause Mortality (ACM) as Per Case Definitions Assessed All-cause mortality CD2	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	—	0.01 Percentage of subjects	—

SECONDARY outcome

Timeframe: From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

Pneumonia of PCD was defined as cough or difficulty breathing (on history) AND tachypnea (\>= 50 breaths per minute \< 1 year, \>= 40 breaths per minute \>= 1year) AND lower chest wall indrawing,SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission,SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission,SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation less than 90%.All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excluding planned admissions for medical investigation/care or elective surgery and trauma).All-cause mortality of CD1 was defined as a fatality (of any cause),of CD2 defined as a fatality (medical cause).Sepsis of CD1 was defined as a child with positive blood culture;CD2 defined as a child with positive salmonella blood culture.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed All-Cause Hospitalization PCD	0.21 Percentage of subjects	0.22 Percentage of subjects	0.24 Percentage of subjects	0.23 Percentage of subjects	0.23 Percentage of subjects	0.24 Percentage of subjects
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed Sepsis CD1	0.02 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed Sepsis CD2	0.01 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed Pneumonia PCD	0.04 Percentage of subjects	0.03 Percentage of subjects	0.03 Percentage of subjects	0.05 Percentage of subjects	0.05 Percentage of subjects	0.05 Percentage of subjects
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed Pneumonia SCD1	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed Pneumonia SCD2	0.03 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.03 Percentage of subjects	0.03 Percentage of subjects	0.03 Percentage of subjects
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed Pneumonia SCD3	0 Percentage of subjects	0 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed All-Cause Mortality CD1	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects
Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed All-Cause Mortality CD2	0.01 Percentage of subjects	0.01 Percentage of subjects	0.01 Percentage of subjects	0.02 Percentage of subjects	0.02 Percentage of subjects	0.01 Percentage of subjects

SECONDARY outcome

Timeframe: From Month 2.5 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Blood transfusion case definition assessed was the case definition 1 (CD1). Blood transfusion of CD1 was defined as a child with inpatient admission with documented blood transfusion.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Percentage of Subjects With Blood Transfusion, as Per Case Definition Assessed	0.03 Percentage of subjects	0.03 Percentage of subjects	0.04 Percentage of subjects	0.03 Percentage of subjects	0.03 Percentage of subjects	0.04 Percentage of subjects

SECONDARY outcome

Timeframe: From Month 2.5 to Month 32

CPFMI of PCD = episode of malaria for which PFAP \> 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). Analysis was performed on subjects aged 5-17 months and 6-12 weeks at enrollment. Results were presented by gender and overall.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2276 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2306 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2336 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2005 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1985 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2007 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Gender and Overall PCD Overall	0.68 events per person-year	0.81 events per person-year	1.15 events per person-year	0.88 events per person-year	0.8 events per person-year	1.03 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Gender and Overall PCD Females	0.72 events per person-year	0.8 events per person-year	1.11 events per person-year	0.79 events per person-year	0.76 events per person-year	1.06 events per person-year
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Gender and Overall PCD Males	0.65 events per person-year	0.81 events per person-year	1.19 events per person-year	0.96 events per person-year	0.83 events per person-year	1.01 events per person-year

SECONDARY outcome

Timeframe: At Month 20 (Booster)

Population: The analysis was performed on the Intent-to-Treat (ITT) population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=5948 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=4358 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2974 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) HAZ	-1.6 z-score Standard Deviation 1	-1.7 z-score Standard Deviation 1.1	-1.6 z-score Standard Deviation 1	—	-1.7 z-score Standard Deviation 1.2	—
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) WAZ	-1 z-score Standard Deviation 1	-0.9 z-score Standard Deviation 1	-1 z-score Standard Deviation 1	—	-0.9 z-score Standard Deviation 1	—
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) MUACZ	-0.3 z-score Standard Deviation 0.9	-0.1 z-score Standard Deviation 1	-0.3 z-score Standard Deviation 0.9	—	-0.1 z-score Standard Deviation 1	—

SECONDARY outcome

Timeframe: At Months 32, 44, at study end (early and late) (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine. Data was not collected for the participants in the 6-12W groups for the HAZ, WAZ, MUACZ categories at Month 44 and at Study end Late time frames.

Anthropometry consisted of length/height for age z-score \[HAZ\] (children \< 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score \[WAZ\] and mid-upper arm circumference for age z-score \[MUACZ\] measurements, where a HAZ \< -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ \> -3 and ≤ -2 z-score indicates a low weight for age, a WAZ \> - 2 z-score indicates normal weight. A MUACZ \< -2 z-score indicates children that are wasted, a MUACZ \< - 3 z-score indicates severely wasted children. Note: The early study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end and to late study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2363 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2382 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2392 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1731 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1726 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1725 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) HAZ, Month 32	-1.3 z-score Standard Deviation 1.0	-1.4 z-score Standard Deviation 1.0	-1.4 z-score Standard Deviation 1.0	-1.4 z-score Standard Deviation 1.1	-1.5 z-score Standard Deviation 1.1	-1.5 z-score Standard Deviation 1.1
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) WAZ, Month 32	-0.9 z-score Standard Deviation 0.9	-1.0 z-score Standard Deviation 0.9	-1.0 z-score Standard Deviation 0.9	-0.9 z-score Standard Deviation 1.0	-0.9 z-score Standard Deviation 1.0	-0.9 z-score Standard Deviation 1.0
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) MUACZ, Month 32	-0.4 z-score Standard Deviation 0.9	-0.4 z-score Standard Deviation 0.9	-0.4 z-score Standard Deviation 0.8	-0.3 z-score Standard Deviation 1.0	-0.4 z-score Standard Deviation 0.9	-0.4 z-score Standard Deviation 1.0
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) HAZ, Month 44	-1.1 z-score Standard Deviation 1.0	-1.2 z-score Standard Deviation 0.9	-1.2 z-score Standard Deviation 1.0	—	—	—
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) WAZ, Month 44	-0.9 z-score Standard Deviation 0.9	-1.0 z-score Standard Deviation 0.9	-0.9 z-score Standard Deviation 0.8	—	—	—
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) MUACZ, Month 44	-0.7 z-score Standard Deviation 0.8	-0.7 z-score Standard Deviation 0.9	-0.6 z-score Standard Deviation 0.8	—	—	—
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) HAZ, Study end Early	-1.3 z-score Standard Deviation 1.0	-1.3 z-score Standard Deviation 1.0	-1.3 z-score Standard Deviation 1.0	-1.4 z-score Standard Deviation 1.0	-1.4 z-score Standard Deviation 1.0	-1.4 z-score Standard Deviation 1.0
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) WAZ, Study end Early	-1.0 z-score Standard Deviation 0.8	-1.0 z-score Standard Deviation 0.8	-1.0 z-score Standard Deviation 0.8	-0.9 z-score Standard Deviation 0.9	-0.9 z-score Standard Deviation 0.9	-0.9 z-score Standard Deviation 0.9
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) MUACZ, Study end Early	-0.8 z-score Standard Deviation 0.9	-0.8 z-score Standard Deviation 0.9	-0.8 z-score Standard Deviation 0.8	-0.4 z-score Standard Deviation 0.9	-0.5 z-score Standard Deviation 0.9	-0.5 z-score Standard Deviation 0.9
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) HAZ, Study end Late	-1.0 z-score Standard Deviation 0.9	-1.1 z-score Standard Deviation 0.9	-1.1 z-score Standard Deviation 1.0	—	—	—
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) WAZ, Study end Late	-0.9 z-score Standard Deviation 0.9	-1.0 z-score Standard Deviation 0.9	-1.0 z-score Standard Deviation 0.8	—	—	—
Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) MUACZ, Study end Late	-0.7 z-score Standard Deviation 0.8	-0.8 z-score Standard Deviation 0.9	-0.7 z-score Standard Deviation 0.8	—	—	—

SECONDARY outcome

Timeframe: At Day 0 and at Month 3

Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 subjects enrolled in each study center.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=1036 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1234 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=529 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=627 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against Plasmodium Falciparum Circumsporozoite (Anti-CS) Anti-CS, Month 3	621 EL.U/mL Interval 591.5 to 651.9	210.5 EL.U/mL Interval 198.2 to 223.6	0.3 EL.U/mL Interval 0.3 to 0.3	—	0.3 EL.U/mL Interval 0.3 to 0.3	—
Antibody Concentrations Against Plasmodium Falciparum Circumsporozoite (Anti-CS) Anti-CS, Day 0	0.3 EL.U/mL Interval 0.3 to 0.3	0.4 EL.U/mL Interval 0.4 to 0.4	0.3 EL.U/mL Interval 0.3 to 0.3	—	0.4 EL.U/mL Interval 0.4 to 0.5	—

SECONDARY outcome

Timeframe: At Day 0 and at Month 3

Population: The analysis was performed on the HIV-ATP population for immunogenicity, which included all children included in the HIV-ITT population who received all vaccinations according to the protocol procedures.

Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=29 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=25 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=17 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=5 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Day 0	0.3 EL.U/mL Interval 0.2 to 0.5	0.3 EL.U/mL Interval 0.2 to 0.4	0.4 EL.U/mL Interval 0.3 to 0.5	—	0.3 EL.U/mL Interval 0.3 to 0.3	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Month 3	264.7 EL.U/mL Interval 137.5 to 509.6	125.3 EL.U/mL Interval 58.1 to 270.3	0.5 EL.U/mL Interval 0.2 to 1.7	—	0.3 EL.U/mL Interval 0.3 to 0.3	—

SECONDARY outcome

Timeframe: At Months 20, 21 and 32

Population: The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center in each age category who received all vaccinations according to the protocol procedures. Data was not collected for the participants in the 5-17M groups for the Manhica site at any given time frame.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=442 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=438 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=426 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=569 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=530 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=554 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Bagamoyo - Month 20	26.6 EL.U/mL Interval 14.2 to 49.9	23.1 EL.U/mL Interval 11.1 to 47.8	0.3 EL.U/mL Interval 0.3 to 0.3	7.6 EL.U/mL Interval 5.1 to 11.4	6.9 EL.U/mL Interval 4.8 to 10.0	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kombewa - Month 21	308.5 EL.U/mL Interval 252.4 to 377.0	37.1 EL.U/mL Interval 26.7 to 51.5	0.4 EL.U/mL Interval 0.3 to 0.4	9.2 EL.U/mL Interval 6.0 to 14.2	146.3 EL.U/mL Interval 96.6 to 221.6	0.4 EL.U/mL Interval 0.3 to 0.5
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kombewa - Month 32	53.8 EL.U/mL Interval 40.3 to 71.7	19.8 EL.U/mL Interval 14.1 to 27.7	0.3 EL.U/mL Interval 0.3 to 0.4	4.3 EL.U/mL Interval 2.8 to 6.6	8.3 EL.U/mL Interval 4.8 to 14.3	0.4 EL.U/mL Interval 0.3 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Lambarene - Month 32	23.0 EL.U/mL Interval 15.6 to 33.9	5.9 EL.U/mL Interval 3.6 to 9.9	0.3 EL.U/mL Interval 0.2 to 0.4	4.1 EL.U/mL Interval 2.9 to 5.8	21.0 EL.U/mL Interval 13.9 to 31.7	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Lilongwe - Month 20	45.9 EL.U/mL Interval 28.6 to 73.8	22.2 EL.U/mL Interval 11.2 to 44.0	0.4 EL.U/mL Interval 0.2 to 0.7	7.4 EL.U/mL Interval 4.7 to 11.5	5.1 EL.U/mL Interval 3.2 to 8.3	0.3 EL.U/mL Interval 0.3 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Overall sites - Month 20	34.4 EL.U/mL Interval 30.7 to 38.6	35.4 EL.U/mL Interval 31.7 to 39.5	0.3 EL.U/mL Interval 0.3 to 0.3	6.6 EL.U/mL Interval 5.8 to 7.5	5.9 EL.U/mL Interval 5.2 to 6.7	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Overall sites - Month 21	318.2 EL.U/mL Interval 295.1 to 343.0	34.2 EL.U/mL Interval 30.5 to 38.3	0.3 EL.U/mL Interval 0.3 to 0.3	6.2 EL.U/mL Interval 5.4 to 7.0	169.9 EL.U/mL Interval 153.8 to 187.7	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Overall sites - Month 32	52.4 EL.U/mL Interval 47.8 to 57.6	19.3 EL.U/mL Interval 17.2 to 21.8	0.3 EL.U/mL Interval 0.3 to 0.3	3.7 EL.U/mL Interval 3.3 to 4.2	15.9 EL.U/mL Interval 13.8 to 18.3	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Agogo - Month 20	34.1 EL.U/mL Interval 24.0 to 48.3	52.1 EL.U/mL Interval 41.3 to 65.7	0.3 EL.U/mL Interval 0.3 to 0.4	5.6 EL.U/mL Interval 3.8 to 8.4	5.1 EL.U/mL Interval 3.4 to 7.6	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Agogo - Month 21	265.0 EL.U/mL Interval 220.9 to 317.9	48.3 EL.U/mL Interval 37.6 to 61.9	0.3 EL.U/mL Interval 0.2 to 0.3	5.3 EL.U/mL Interval 3.5 to 8.0	137.6 EL.U/mL Interval 95.0 to 199.3	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Agogo - Month 32	46.3 EL.U/mL Interval 34.8 to 61.6	28.8 EL.U/mL Interval 21.8 to 37.9	0.3 EL.U/mL Interval 0.2 to 0.3	2.9 EL.U/mL Interval 1.9 to 4.5	14.8 EL.U/mL Interval 9.5 to 23.1	0.3 EL.U/mL Interval 0.3 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Bagamoyo - Month 21	306.6 EL.U/mL Interval 206.5 to 455.4	31.8 EL.U/mL Interval 19.4 to 52.2	0.6 EL.U/mL Interval 0.2 to 1.4	7.2 EL.U/mL Interval 4.5 to 11.6	169.9 EL.U/mL Interval 129.8 to 222.5	0.3 EL.U/mL Interval 0.2 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Bagamoyo - Month 32	44.6 EL.U/mL Interval 27.2 to 73.3	16.9 EL.U/mL Interval 10.2 to 27.9	0.3 EL.U/mL Interval 0.3 to 0.3	3.7 EL.U/mL Interval 2.4 to 5.7	14.4 EL.U/mL Interval 9.6 to 21.7	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kilifi - Month 20	34.3 EL.U/mL Interval 26.3 to 44.7	33.1 EL.U/mL Interval 26.3 to 41.6	0.3 EL.U/mL Interval 0.3 to 0.3	6.1 EL.U/mL Interval 4.0 to 9.4	6.6 EL.U/mL Interval 4.6 to 9.6	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kilifi - Month 21	308.4 EL.U/mL Interval 251.8 to 377.7	24.3 EL.U/mL Interval 18.1 to 32.8	0.3 EL.U/mL Interval 0.3 to 0.3	5.3 EL.U/mL Interval 3.4 to 8.2	229.3 EL.U/mL Interval 175.4 to 299.9	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kilifi - Month 32	59.4 EL.U/mL Interval 45.7 to 77.2	14.9 EL.U/mL Interval 11.0 to 20.2	0.3 EL.U/mL Interval 0.2 to 0.4	2.8 EL.U/mL Interval 1.8 to 4.4	19.8 EL.U/mL Interval 14.1 to 27.8	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kintampo - Month 20	50.8 EL.U/mL Interval 37.2 to 69.5	36.6 EL.U/mL Interval 26.4 to 50.7	0.4 EL.U/mL Interval 0.3 to 0.5	3.7 EL.U/mL Interval 2.5 to 5.6	3.8 EL.U/mL Interval 2.5 to 5.8	0.3 EL.U/mL Interval 0.3 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kintampo - Month 21	266.8 EL.U/mL Interval 188.9 to 377.0	41.2 EL.U/mL Interval 31.2 to 54.6	0.3 EL.U/mL Interval 0.2 to 0.3	3.2 EL.U/mL Interval 2.0 to 5.0	128.8 EL.U/mL Interval 95.7 to 173.4	0.3 EL.U/mL Interval 0.3 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kintampo - Month 32	70.9 EL.U/mL Interval 55.2 to 90.9	20.2 EL.U/mL Interval 14.3 to 28.5	0.4 EL.U/mL Interval 0.3 to 0.5	2.2 EL.U/mL Interval 1.4 to 3.4	13.3 EL.U/mL Interval 8.1 to 21.9	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Kombewa - Month 20	39.8 EL.U/mL Interval 29.9 to 53.0	46.6 EL.U/mL Interval 33.2 to 65.3	0.3 EL.U/mL Interval 0.3 to 0.4	8.7 EL.U/mL Interval 5.8 to 13.0	5.5 EL.U/mL Interval 3.6 to 8.4	0.4 EL.U/mL Interval 0.3 to 0.5
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Korogwe - Month 20	29.4 EL.U/mL Interval 21.4 to 40.4	28.2 EL.U/mL Interval 22.5 to 35.3	0.3 EL.U/mL Interval 0.3 to 0.3	8.1 EL.U/mL Interval 5.2 to 12.7	7.9 EL.U/mL Interval 5.3 to 11.8	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Korogwe - Month 21	305.6 EL.U/mL Interval 266.4 to 350.5	27.1 EL.U/mL Interval 20.7 to 35.5	0.3 EL.U/mL Interval 0.2 to 0.3	7.6 EL.U/mL Interval 4.8 to 11.9	178.3 EL.U/mL Interval 141.2 to 225.1	0.3 EL.U/mL Interval 0.2 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Korogwe - Month 32	47.4 EL.U/mL Interval 37.5 to 59.9	16.8 EL.U/mL Interval 13.1 to 21.7	0.3 EL.U/mL Interval 0.2 to 0.3	4.9 EL.U/mL Interval 3.0 to 7.9	19.6 EL.U/mL Interval 13.0 to 29.6	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Lambarene - Month 20	8.2 EL.U/mL Interval 5.8 to 11.6	11.1 EL.U/mL Interval 7.0 to 17.6	0.3 EL.U/mL Interval 0.2 to 0.3	8.3 EL.U/mL Interval 5.8 to 12.1	7.7 EL.U/mL Interval 5.1 to 11.6	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Lambarene - Month 21	203.6 EL.U/mL Interval 155.1 to 267.3	10.6 EL.U/mL Interval 6.6 to 16.8	0.3 EL.U/mL Interval 0.2 to 0.3	7.4 EL.U/mL Interval 5.0 to 10.8	251.3 EL.U/mL Interval 184.8 to 341.7	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Lilongwe - Month 21	285.0 EL.U/mL Interval 228.5 to 355.4	17.0 EL.U/mL Interval 8.1 to 35.7	0.3 EL.U/mL Interval 0.2 to 0.4	8.0 EL.U/mL Interval 5.2 to 12.1	126.1 EL.U/mL Interval 92.7 to 171.5	0.3 EL.U/mL Interval 0.2 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Lilongwe - Month 32	45.6 EL.U/mL Interval 28.8 to 72.3	12.7 EL.U/mL Interval 6.4 to 25.3	0.3 EL.U/mL Interval 0.2 to 0.4	4.5 EL.U/mL Interval 3.1 to 6.6	15.4 EL.U/mL Interval 9.3 to 25.4	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Nanoro - Month 20	57.2 EL.U/mL Interval 43.4 to 75.4	61.8 EL.U/mL Interval 46.3 to 82.4	0.3 EL.U/mL Interval 0.3 to 0.3	3.2 EL.U/mL Interval 2.1 to 4.7	2.7 EL.U/mL Interval 1.7 to 4.4	0.3 EL.U/mL Interval 0.3 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Nanoro - Month 21	520.5 EL.U/mL Interval 443.4 to 611.1	71.1 EL.U/mL Interval 54.8 to 92.3	0.3 EL.U/mL Interval 0.2 to 0.3	3.1 EL.U/mL Interval 2.0 to 4.6	163.2 EL.U/mL Interval 121.4 to 219.4	0.3 EL.U/mL Interval 0.3 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Nanoro - Month 32	69.2 EL.U/mL Interval 55.2 to 86.9	35.0 EL.U/mL Interval 25.7 to 47.9	0.3 EL.U/mL Interval 0.3 to 0.3	2.8 EL.U/mL Interval 2.0 to 4.0	11.9 EL.U/mL Interval 7.4 to 19.2	0.5 EL.U/mL Interval 0.4 to 0.6
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Siaya - Month 20	28.4 EL.U/mL Interval 18.4 to 44.0	32.8 EL.U/mL Interval 21.6 to 50.1	0.3 EL.U/mL Interval 0.3 to 0.4	8.9 EL.U/mL Interval 5.5 to 14.2	7.0 EL.U/mL Interval 4.2 to 11.5	0.4 EL.U/mL Interval 0.3 to 0.5
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Siaya - Month 21	398.1 EL.U/mL Interval 324.6 to 488.2	36.4 EL.U/mL Interval 22.6 to 58.6	0.3 EL.U/mL Interval 0.2 to 0.4	8.4 EL.U/mL Interval 5.2 to 13.6	171.5 EL.U/mL Interval 109.8 to 267.9	0.4 EL.U/mL Interval 0.3 to 0.5
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Siaya - Month 32	55.8 EL.U/mL Interval 41.4 to 75.3	21.7 EL.U/mL Interval 13.4 to 35.1	0.4 EL.U/mL Interval 0.3 to 0.5	5.5 EL.U/mL Interval 3.3 to 9.2	23.6 EL.U/mL Interval 14.2 to 39.1	0.5 EL.U/mL Interval 0.4 to 0.7
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Manhica - Month 20	—	—	—	14.7 EL.U/mL Interval 10.0 to 21.5	12.3 EL.U/mL Interval 8.4 to 18.1	0.3 EL.U/mL Interval 0.3 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Manhica - Month 21	—	—	—	12.3 EL.U/mL Interval 7.7 to 19.5	260.2 EL.U/mL Interval 176.4 to 383.8	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Manhica - Month 32	—	—	—	6.8 EL.U/mL Interval 4.0 to 11.5	25.4 EL.U/mL Interval 14.8 to 43.5	0.3 EL.U/mL Interval 0.3 to 0.3

SECONDARY outcome

Timeframe: At Month 44 and at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=104 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=101 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=98 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=103 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=101 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=131 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Agogo - Month 44	27.7 EL.U/mL Interval 20.1 to 38.1	17.9 EL.U/mL Interval 13.5 to 23.6	0.3 EL.U/mL Interval 0.2 to 0.3	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Agogo - Study end	23.2 EL.U/mL Interval 16.7 to 32.3	17.2 EL.U/mL Interval 12.7 to 23.3	0.3 EL.U/mL Interval 0.2 to 0.3	2.1 EL.U/mL Interval 1.3 to 3.4	6.1 EL.U/mL Interval 3.2 to 11.4	0.3 EL.U/mL Interval 0.2 to 0.4
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Lilongwe - Month 44	30.5 EL.U/mL Interval 21.4 to 43.5	8.5 EL.U/mL Interval 4.5 to 15.9	0.3 EL.U/mL Interval 0.2 to 0.3	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Lilongwe - Study end	26.9 EL.U/mL Interval 18.3 to 39.5	7.2 EL.U/mL Interval 4.1 to 12.5	0.3 EL.U/mL Interval 0.3 to 0.3	2.8 EL.U/mL Interval 1.8 to 4.2	10.9 EL.U/mL Interval 6.3 to 18.7	0.3 EL.U/mL Interval 0.2 to 0.3
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Siaya - Month 44	41.4 EL.U/mL Interval 29.7 to 57.9	21.2 EL.U/mL Interval 14.0 to 32.0	0.5 EL.U/mL Interval 0.4 to 0.8	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Siaya - Study end	27.4 EL.U/mL Interval 19.4 to 38.9	15.8 EL.U/mL Interval 10.2 to 24.4	0.4 EL.U/mL Interval 0.3 to 0.6	3.3 EL.U/mL Interval 1.9 to 5.6	10.4 EL.U/mL Interval 6.1 to 17.7	0.4 EL.U/mL Interval 0.3 to 0.6
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Overall - Month 44	33.0 EL.U/mL Interval 26.9 to 40.3	16.8 EL.U/mL Interval 13.5 to 21.0	0.3 EL.U/mL Interval 0.3 to 0.4	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) Anti-CS, Overall - Study end	25.4 EL.U/mL Interval 20.6 to 31.2	14.4 EL.U/mL Interval 11.4 to 18.1	0.3 EL.U/mL Interval 0.3 to 0.4	2.6 EL.U/mL Interval 2.0 to 3.4	8.9 EL.U/mL Interval 6.5 to 12.3	0.3 EL.U/mL Interval 0.3 to 0.4

SECONDARY outcome

Timeframe: At Month 3

Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=545 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=639 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile Anti-CS, Tertile 1	264.15 EL.U/mL Interval 238.2 to 292.9	78.45 EL.U/mL Interval 69.4 to 88.6	—	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile Anti-CS, Tertile 2	613.79 EL.U/mL Interval 598.3 to 629.7	230.68 EL.U/mL Interval 224.7 to 236.8	—	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile Anti-CS, Tertile 3	1351.41 EL.U/mL Interval 1276.3 to 1431.0	592.65 EL.U/mL Interval 557.8 to 629.6	—	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile Anti-CS, Across Tertiles	603.77 EL.U/mL Interval 563.6 to 646.8	220.9 EL.U/mL Interval 204.1 to 239.0	—	—	—	—

SECONDARY outcome

Timeframe: From Month 2.5 to Month 32

CPFMI of PCD = episode of malaria for which PFAP \> 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post primary vaccination pooled across sites, on subjects in GSK257049-Menjugate Groups (5-17M; 6-12W) and Comparator Groups (5-17M; 6-12W), taking into account the first 200 participants per site.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=182 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=565 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=214 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=677 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile Tertile 1	0.68 events per person-year	1.21 events per person-year	1.29 events per person-year	—	0.93 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile Tertile 2	0.78 events per person-year	1.21 events per person-year	0.7 events per person-year	—	0.93 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile Tertile 3	1.03 events per person-year	1.21 events per person-year	0.58 events per person-year	—	0.93 events per person-year	—

SECONDARY outcome

Timeframe: At Month 21

Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=465 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=546 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile Anti-CS, Tertile 1	138.15 EL.U/mL Interval 123.5 to 154.5	47.99 EL.U/mL Interval 41.2 to 55.9	—	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile Anti-CS, Tertile 2	311.35 EL.U/mL Interval 303.4 to 319.6	194.85 EL.U/mL Interval 189.9 to 200.0	—	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile Anti-CS, Tertile 3	675.24 EL.U/mL Interval 632.8 to 720.5	479.44 EL.U/mL Interval 446.8 to 514.5	—	—	—	—
Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile Anti-CS, Across Tertiles	307.93 EL.U/mL Interval 286.2 to 331.3	165.31 EL.U/mL Interval 150.0 to 182.2	—	—	—	—

SECONDARY outcome

Timeframe: From Booster at Month 20 to Month 32

CPFMI of PCD = episode of malaria for which PFAP \> 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post booster vaccination pooled across sites, on subjects in R3R (5-17M; 6-12W) (or R3R below) and C3C (5-17M; 6-12W) (or C3C below) groups taking into account the first 200 participants per site.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=156 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=479 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=420 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=594 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile Tertile 2	0.68 events per person-year	1.21 events per person-year	0.84 events per person-year	—	0.94 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile Tertile 1	0.68 events per person-year	1.21 events per person-year	0.99 events per person-year	—	0.94 events per person-year	—
Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile Tertile 3	0.77 events per person-year	1.21 events per person-year	0.64 events per person-year	—	0.94 events per person-year	—

SECONDARY outcome

Timeframe: At Day 0 and at Month 3

Population: The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center, for each age category who received all vaccinations according to the protocol procedures.

Antibody concentrations assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=1029 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1213 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=526 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=627 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) Anti-HBs, Day 0	166.3 mIU/mL Interval 148.0 to 186.8	8.6 mIU/mL Interval 8.0 to 9.3	168.6 mIU/mL Interval 142.8 to 199.2	—	8.5 mIU/mL Interval 7.7 to 9.4	—
Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) Anti-HBs, Month 3	81567.7 mIU/mL Interval 75442.7 to 88189.9	13674.3 mIU/mL Interval 12811.5 to 14595.3	127.5 mIU/mL Interval 108.8 to 149.4	—	728.8 mIU/mL Interval 643.6 to 825.2	—

SECONDARY outcome

Timeframe: At Day 0 and at Month 3

Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=29 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=25 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=17 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=5 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against Hepatitis B Surface Antigen Anti-HBs, Day 0	98.6 mIU/mL Interval 43.8 to 222.0	7.5 mIU/mL Interval 4.8 to 11.6	63.6 mIU/mL Interval 19.4 to 208.4	—	5 mIU/mL Interval 5.0 to 5.0	—
Antibody Concentrations Against Hepatitis B Surface Antigen Anti-HBs, Month 3	37476.5 mIU/mL Interval 17766.0 to 79054.9	1996.2 mIU/mL Interval 561.6 to 7095.8	37.1 mIU/mL Interval 9.1 to 151.9	—	197.2 mIU/mL Interval 7.7 to 5081.7	—

SECONDARY outcome

Timeframe: At Months 20 and 21

Population: The analysis was performed on the ATP population for HBs immunogenicity post booster, which included the first 200 children enrolled in Korogwe, Lamberene and Lilongwe study centers in each age category who received the booster dose of GSK257049 vaccine and all vaccinations according to the protocol procedures.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=95 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=134 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) Anti-HBs, Month 20	5068.5 mIU/mL Interval 3711.3 to 6922.0	1532.5 mIU/mL Interval 1240.6 to 1893.2	—	—	—	—
Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) Anti-HBs, Month 21	95206.4 mIU/mL Interval 72395.4 to 125204.9	116458.1 mIU/mL Interval 86865.7 to 156131.6	—	—	—	—

SECONDARY outcome

Timeframe: At Day 0 and at Month 3

Population: The ATP population for Polio Sabin™ immunogenicity included all subjects from the ATP population for immunogenicity (minus those who received ≥ 2 doses of Polio Sabin™ vaccine prior to Dose 1 of study vaccine, or who received at least one dose of a polio vaccine in co-administration with the study vaccine before one month post Dose 3 blood sample.

Anti-Polio 1, 2 and 3 antibody titers were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was an antibody titer ≥ 1:8.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=931 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=474 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3 Anti-Polio 1, Day 0	47.4 Titer Interval 41.7 to 53.8	43.3 Titer Interval 36.2 to 51.9	—	—	—	—
Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3 Anti-Polio 1, Month 3	334.9 Titer Interval 295.2 to 379.8	417.6 Titer Interval 351.4 to 496.2	—	—	—	—
Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3 Anti-Polio 2, Month 3	372.1 Titer Interval 334.5 to 414.0	450.8 Titer Interval 393.9 to 516.0	—	—	—	—
Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3 Anti-Polio 3, Day 0	9.4 Titer Interval 8.6 to 10.3	9.1 Titer Interval 8.0 to 10.3	—	—	—	—
Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3 Anti-Polio 3, Month 3	80.0 Titer Interval 71.0 to 90.1	95.9 Titer Interval 82.0 to 112.2	—	—	—	—
Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3 Anti-Polio 2, Day 0	38.6 Titer Interval 34.6 to 43.2	40.3 Titer Interval 34.2 to 47.5	—	—	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine and had their symptom sheets filled in.

Assessed solicited local symptoms included pain, redness and swelling. Any = the incidence of a particular symptom, regardless of intensity grade. Grade 3 pain = cried when limb was moved, spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=1479 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=721 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1462 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=738 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	247 Participants	61 Participants	435 Participants	—	215 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Participants	0 Participants	10 Participants	—	7 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	66 Participants	26 Participants	176 Participants	—	89 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	2 Participants	0 Participants	3 Participants	—	3 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	140 Participants	77 Participants	227 Participants	—	125 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	6 Participants	0 Participants	27 Participants	—	29 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	179 Participants	41 Participants	383 Participants	—	178 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	3 Participants	0 Participants	5 Participants	—	3 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	26 Participants	18 Participants	124 Participants	—	90 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	3 Participants	0 Participants	3 Participants	—	1 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	140 Participants	50 Participants	228 Participants	—	128 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	15 Participants	0 Participants	29 Participants	—	17 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 3	108 Participants	22 Participants	345 Participants	—	153 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 3	0 Participants	0 Participants	8 Participants	—	2 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 3	42 Participants	13 Participants	113 Participants	—	63 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 3	2 Participants	0 Participants	1 Participants	—	1 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 3	134 Participants	35 Participants	185 Participants	—	111 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 3	9 Participants	0 Participants	9 Participants	—	12 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	401 Participants	105 Participants	705 Participants	—	342 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	3 Participants	0 Participants	23 Participants	—	12 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	122 Participants	49 Participants	292 Participants	—	163 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	6 Participants	0 Participants	7 Participants	—	5 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	303 Participants	119 Participants	427 Participants	—	248 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	25 Participants	0 Participants	59 Participants	—	53 Participants	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine and had their symptom sheets filled in.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=1479 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1462 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=721 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=738 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 1	91 Participants	164 Participants	27 Participants	—	65 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 1	3 Participants	1 Participants	0 Participants	—	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 1	33 Participants	88 Participants	8 Participants	—	26 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	29 Participants	5 Participants	7 Participants	—	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 2	61 Participants	74 Participants	26 Participants	—	15 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 2	192 Participants	289 Participants	45 Participants	—	123 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 3	52 Participants	49 Participants	16 Participants	—	19 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 3	138 Participants	287 Participants	27 Participants	—	104 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 3	1 Participants	3 Participants	0 Participants	—	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 3	138 Participants	106 Participants	40 Participants	—	45 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 3	76 Participants	44 Participants	18 Participants	—	20 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Across doses	230 Participants	285 Participants	78 Participants	—	121 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Across doses	5 Participants	2 Participants	0 Participants	—	2 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Across doses	3 Participants	17 Participants	0 Participants	—	5 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Across doses	207 Participants	363 Participants	54 Participants	—	139 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Across doses	398 Participants	243 Participants	132 Participants	—	104 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 3	76 Participants	144 Participants	15 Participants	—	54 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 1	165 Participants	370 Participants	41 Participants	—	157 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 1	0 Participants	10 Participants	0 Participants	—	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 1	64 Participants	226 Participants	16 Participants	—	84 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 1	202 Participants	124 Participants	71 Participants	—	52 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 1	3 Participants	2 Participants	0 Participants	—	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 1	71 Participants	67 Participants	24 Participants	—	24 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	385 Participants	459 Participants	108 Participants	—	192 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	200 Participants	326 Participants	52 Participants	—	127 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 2	99 Participants	135 Participants	37 Participants	—	55 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 2	1 Participants	0 Participants	0 Participants	—	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 2	2 Participants	7 Participants	0 Participants	—	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 2	114 Participants	175 Participants	28 Participants	—	57 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 2	151 Participants	105 Participants	47 Participants	—	43 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 2	0 Participants	0 Participants	0 Participants	—	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 2	89 Participants	60 Participants	24 Participants	—	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	503 Participants	411 Participants	100 Participants	—	154 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	42 Participants	9 Participants	10 Participants	—	6 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	267 Participants	278 Participants	42 Participants	—	89 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 3	97 Participants	124 Participants	29 Participants	—	44 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 3	1 Participants	1 Participants	0 Participants	—	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 3	2 Participants	0 Participants	0 Participants	—	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 3	457 Participants	429 Participants	77 Participants	—	111 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 3	39 Participants	13 Participants	7 Participants	—	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 3	262 Participants	280 Participants	32 Participants	—	57 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Across doses	121 Participants	144 Participants	44 Participants	—	51 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Across doses	369 Participants	574 Participants	96 Participants	—	244 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Across doses	5 Participants	2 Participants	0 Participants	—	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Across doses	206 Participants	128 Participants	61 Participants	—	41 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	897 Participants	839 Participants	235 Participants	—	331 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	105 Participants	26 Participants	24 Participants	—	11 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	547 Participants	598 Participants	110 Participants	—	209 Participants	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-booster vaccination period

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=641 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=639 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=633 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=625 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=608 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=621 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	109 Participants	45 Participants	41 Participants	29 Participants	59 Participants	25 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	42 Participants	35 Participants	30 Participants	28 Participants	45 Participants	43 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	15 Participants	13 Participants	8 Participants	12 Participants	9 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	9 Participants	1 Participants	0 Participants	0 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-booster vaccination period

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=641 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=639 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=633 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=625 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=608 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=621 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability	40 Participants	12 Participants	8 Participants	10 Participants	27 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite	66 Participants	27 Participants	21 Participants	27 Participants	45 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite	39 Participants	14 Participants	13 Participants	8 Participants	26 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	233 Participants	70 Participants	45 Participants	52 Participants	152 Participants	58 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	151 Participants	29 Participants	16 Participants	15 Participants	80 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness	55 Participants	22 Participants	21 Participants	19 Participants	33 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness	34 Participants	10 Participants	13 Participants	6 Participants	19 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability	63 Participants	25 Participants	18 Participants	23 Participants	46 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	34 Participants	6 Participants	5 Participants	7 Participants	9 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-booster vaccination period, at Month 20 + 7 Day (Days 0-6)

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Diagnostic certainty levels included: Level 1- Witnessed sudden loss of consciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 2- History of unconsciousness and generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations; Level 3- History of unconsciousness and other generalized motor manifestations; Level 4- Reported generalized convulsive seizure with insufficient evidence to meet the case definition; Level 5- Not a case of generalized convulsive seizure.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2447 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2472 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2473 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Menjugate Comparator [6-12W] Group n=1825 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1827 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Doses With Seizures by Diagnostic Certainty Level Level 1	1 Doses	1 Doses	0 Doses	1 Doses	0 Doses
Number of Doses With Seizures by Diagnostic Certainty Level Level 2	5 Doses	2 Doses	1 Doses	3 Doses	1 Doses
Number of Doses With Seizures by Diagnostic Certainty Level Level 3	0 Doses	0 Doses	0 Doses	0 Doses	0 Doses
Number of Doses With Seizures by Diagnostic Certainty Level Level 4	1 Doses	0 Doses	0 Doses	0 Doses	0 Doses
Number of Doses With Seizures by Diagnostic Certainty Level Level 5	1 Doses	1 Doses	0 Doses	0 Doses	0 Doses

SECONDARY outcome

Timeframe: During the 30-day (Days 0-29) post-booster vaccination

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Levels of mucocutaneous changes reported were: cutaneous and mucosal change; cutaneous only change; mucosal only change; cutaneous change focused on the nappy/diaper area. Mucocutaneous changes results calculated based on the first 200 subjects in the 6-12 weeks age category in each study center were enrolled, and with available data (i.e. who received a booster dose).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=605 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=617 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=614 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects Reporting Mucocutaneous Changes (All Levels)	64 Participants	47 Participants	59 Participants	—	—	—

SECONDARY outcome

Timeframe: At Month 0 until study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Meningitis and encephalitis SAEs included: meningitis/encephalitis; meningitis/encephalitis viral; meningism; meningitis haemophilus; meningitis meningococcal; meningitis pneumococcal; meningitis tuberculous; encephalomyelitis.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2976 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2972 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2974 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2178 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2180 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects Reporting Any Meningitis and Encephalitis Serious Adverse Events (SAEs)	15 Participants	12 Participants	5 Participants	8 Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: From Booster up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Meningitis and encephalitis SAEs included: meningitis/encephalitis; meningitis haemophilus; meningitis meningococcal; meningitis tuberculous; encephalomyelitis.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2681 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2719 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2702 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1996 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1966 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1976 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects Reporting Any Meningitis and Encephalitis SAEs	4 Participants	4 Participants	0 Participants	2 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From Month 0 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2976 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2972 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2974 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2178 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2180 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs)	5 Participants	1 Participants	4 Participants	1 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-primary vaccination period

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=1479 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1462 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=721 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=738 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	1273 Participants	1161 Participants	626 Participants	—	600 Participants	—

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-primary vaccination period

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=3997 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=4358 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2003 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal	399 Participants	578 Participants	72 Participants	—	231 Participants	—

SECONDARY outcome

Timeframe: Within the 30-day (days 0-29) post-booster vaccination period

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=641 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=639 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=633 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=625 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=608 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=621 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Any Unsolicited AEs	232 Participants	205 Participants	215 Participants	239 Participants	231 Participants	240 Participants

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-primary and post-booster vaccination period in HIV-infected children

Population: The analysis was performed on the HIV-ITT population, which included all children who received at least one dose of GSK257049 vaccine and were identified as HIV-infected, that is, confirmed to be HIV-infected via identification as positive for HIV by Polymerase Chain Reaction (PCR), or by antibody at 18 months or older.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the subgroup of the first 200 subjects enrolled in each study center, who were reported with HIV infected status ((HIV status either as per general medical history taken at screening or as identified by morbidity surveillance).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=84 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=33 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=35 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=41 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal Any AE(s), post-primary vaccination	13 Participants	0 Participants	0 Participants	—	3 Participants	—
Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal Any AE(s), post-booster vaccination	0 Participants	2 Participants	0 Participants	—	0 Participants	—

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-primary vaccination period in HIV-infected children

Population: The analysis was performed on the HIV-ITT population, which included low-weight and very low-weight children who received at least one dose of GSK257049 vaccine and were identified as HIV-infected, that is, confirmed to be HIV-infected via identification as positive for HIV by Polymerase Chain Reaction (PCR), or by antibody at 18 months or older.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=695 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=221 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=364 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=126 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal in the Low-weight (LW) and Very Low-weight (VLW) Category Any AE(s), in LW	68 Participants	38 Participants	21 Participants	—	17 Participants	—
Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal in the Low-weight (LW) and Very Low-weight (VLW) Category Any AE(s), in VLW	27 Participants	24 Participants	6 Participants	—	10 Participants	—

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-booster vaccination period

Population: The analysis was performed on a subset of subjects from the ITT population, which included low-weight (LW) and very low-weight (VLW) children who received at least one dose of study vaccine.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the subgroup of the first 200 subjects enrolled in each study center. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was \> -3 and ≤ -2. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=273 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=297 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=293 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=208 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=230 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=195 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Unsolicited AEs Related to Vaccination in the Low-weight (LW) and Very Low-weight (VLW) Category Any AE(s) in VLW	5 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Unsolicited AEs Related to Vaccination in the Low-weight (LW) and Very Low-weight (VLW) Category Any AE(s) in LW	4 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From Month 0 up to Month 14

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=5948 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=4358 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2974 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Serious Adverse Events (SAEs)	1040 Participants	782 Participants	634 Participants	—	419 Participants	—

SECONDARY outcome

Timeframe: During the 30-day (Days 0-29) post-primary vaccination period

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=5948 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=4358 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2974 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Serious Adverse Events (SAEs)	312 Participants	192 Participants	181 Participants	—	96 Participants	—

SECONDARY outcome

Timeframe: From Month 0 up to Month 20

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=5948 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=4358 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2974 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Serious Adversee Events (SAEs)	1108 Participants	959 Participants	676 Participants	—	503 Participants	—

SECONDARY outcome

Timeframe: From Booster (at Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2681 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2719 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2702 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1996 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1966 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1976 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Serious Adverse Events (SAEs)	276 Participants	316 Participants	287 Participants	193 Participants	180 Participants	201 Participants

SECONDARY outcome

Timeframe: From Month 0 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Population: The analysis was performed, across age categories for which groups were pooled from the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2976 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2972 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2974 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=2178 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2180 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=2179 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Serious Adverse Events (SAEs)	720 Participants	752 Participants	846 Participants	602 Participants	580 Participants	619 Participants

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-booster vaccination period

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=2447 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2472 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=2473 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1837 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1825 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1827 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Serious Adverse Events (SAEs)	34 Participants	22 Participants	27 Participants	19 Participants	19 Participants	20 Participants

SECONDARY outcome

Timeframe: From Month 0 up to Booster (Month 20), from Month 0 up to study end and from Month 20 up to study end

Population: The analysis was performed on a subset of subjects from the ITT population, which included all children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=51 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=54 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=48 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Serious Adverse Events (SAEs) Any SAE(s), Month 0 - Month 20	43 Participants	39 Participants	36 Participants	—	—	—
Number of Subjects With Serious Adverse Events (SAEs) Any SAE(s), Month 0 - Study end	47 Participants	46 Participants	42 Participants	—	—	—
Number of Subjects With Serious Adverse Events (SAEs) Any SAE(s), Month 20 - Study end	19 Participants	19 Participants	16 Participants	—	—	—

SECONDARY outcome

Timeframe: From Month 0 up to Month 20

Population: The analysis was performed on the ITT population, which included low weight (LW) children who received at least one dose of study vaccine.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was \> -3 and ≤ -2.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=695 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=221 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=364 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=126 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Low-weight (LW) Subjects With Serious Adverse Events (SAEs)	174 Participants	63 Participants	89 Participants	—	38 Participants	—

SECONDARY outcome

Timeframe: From Booster (Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Population: The analysis was performed on a subset of subjects from the ITT population, which included low weight (LW) children who received at least one dose of study vaccine.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=277 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=304 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=297 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=211 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=232 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=195 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Low-weight (LW) Subjects With Serious Adverse Events (SAEs)	32 Participants	40 Participants	38 Participants	21 Participants	34 Participants	24 Participants

SECONDARY outcome

Timeframe: From Month 0 up to Month 20

Population: The analysis was performed on a subset of subjects from the ITT population, which included very-low weight (VLW) children who received at least one dose of study vaccine.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=207 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=147 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=97 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=67 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Very Low-weight (VLW) Subjects With Serious Adverse Events (SAEs)	55 Participants	48 Participants	28 Participants	—	17 Participants	—

SECONDARY outcome

Timeframe: From Booster (Month 20) up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)]

Population: The analysis was performed on a subset of subjects from the ITT population, which included very-low weight (VLW) children who received at least one dose of study vaccine.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=48 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=50 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=60 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=47 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=48 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=68 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Very Low-weight Subjects With Serious Adverse Events (SAEs)	5 Participants	8 Participants	11 Participants	9 Participants	6 Participants	15 Participants

SECONDARY outcome

Timeframe: From Month 0 up to study end (SE - median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Population: The analysis was performed on the ITT population, which included all children who received at least one dose of study vaccine.

Mortality was presented as overall mortality (up to Month 20 and up to study end), mortality due to severe malaria as per secondary case definition(SCD), cerebral malaria as per secondary case definition (SCD), meningitis, fatal all-cause traumas and fatal malaria. SCD= Plasmodium falciparum malaria \> 5000 parasites/mcL and 1 or more markers of severe malaria (prostration, respiratory distress, Blantyre score ≤ 2, seizures 2 or more, hypoglycemia \< 2.2 mmol/L, acidosis BE ≤ -10.0 mmol/L,lactate ≥ 5.0 mmol/L, anemia \< 5.0 g/dL.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=1509 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1500 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	VeroRab Comparator [5-17M] Group n=1503 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	GSK257049 - Menjugate [6-12W] Group n=1118 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1116 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Menjugate Comparator [6-12W] Group n=1100 Participants Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Number of Subjects With Fatal Outcomes, by Gender Overall Mortality (M0-SE), Males	26 Participants	19 Participants	29 Participants	26 Participants	24 Participants	26 Participants
Number of Subjects With Fatal Outcomes, by Gender Severe Malaria SCD, All, Females	75 Participants	107 Participants	100 Participants	49 Participants	57 Participants	75 Participants
Number of Subjects With Fatal Outcomes, by Gender Severe Malaria SCD, All, Males	87 Participants	115 Participants	134 Participants	80 Participants	78 Participants	79 Participants
Number of Subjects With Fatal Outcomes, by Gender Severe Malaria SCD, Fatal, Females	4 Participants	4 Participants	2 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Fatal Outcomes, by Gender Severe Malaria SCD, Fatal, Males	3 Participants	4 Participants	2 Participants	2 Participants	2 Participants	2 Participants
Number of Subjects With Fatal Outcomes, by Gender Cerebral Malaria SCD, All, Males	10 Participants	14 Participants	9 Participants	7 Participants	9 Participants	3 Participants
Number of Subjects With Fatal Outcomes, by Gender Meningitis, Fatal, Males	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Fatal Outcomes, by Gender Fatal All-Cause Traumas, Males	4 Participants	1 Participants	3 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Fatal Outcomes, by Gender Fatal Malaria, Females	9 Participants	8 Participants	4 Participants	4 Participants	5 Participants	3 Participants
Number of Subjects With Fatal Outcomes, by Gender Overall Mortality (M0-M20), Females	27 Participants	20 Participants	14 Participants	24 Participants	20 Participants	13 Participants
Number of Subjects With Fatal Outcomes, by Gender Overall Mortality (M0-SE), Females	35 Participants	32 Participants	17 Participants	29 Participants	27 Participants	16 Participants
Number of Subjects With Fatal Outcomes, by Gender Overall Mortality (M0-M20), Males	19 Participants	8 Participants	19 Participants	20 Participants	20 Participants	21 Participants
Number of Subjects With Fatal Outcomes, by Gender Cerebral Malaria SCD, All, Females	16 Participants	14 Participants	7 Participants	5 Participants	1 Participants	7 Participants
Number of Subjects With Fatal Outcomes, by Gender Cerebral Malaria SCD, Fatal, Females	3 Participants	4 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Fatal Outcomes, by Gender Cerebral Malaria SCD, Fatal, Males	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Fatal Outcomes, by Gender Meningitis, All, Females	5 Participants	5 Participants	1 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Fatal Outcomes, by Gender Meningitis, All, Males	6 Participants	5 Participants	2 Participants	5 Participants	3 Participants	3 Participants
Number of Subjects With Fatal Outcomes, by Gender Meningitis, Fatal, Females	2 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Fatal Outcomes, by Gender Fatal All-Cause Traumas, Females	3 Participants	4 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Fatal Outcomes, by Gender Fatal Malaria, Males	4 Participants	9 Participants	8 Participants	8 Participants	3 Participants	3 Participants

Adverse Events

GSK257049 [5-17M] Group

Serious events: 1475 serious events

Other events: 1410 other events

Deaths: 112 deaths

GSK257049 [6-12W] Group

Serious events: 1186 serious events

Other events: 1360 other events

Deaths: 46 deaths

VeroRab Comparator [5-17M] Group

Serious events: 848 serious events

Other events: 664 other events

Deaths: 106 deaths

Menjugate Comparator [6-12W] Group

Serious events: 622 serious events

Other events: 691 other events

Deaths: 42 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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