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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00866619
• Collaborator: The PATH Malaria Vaccine Initiative (MVI) (Other)
• Enrollment: 15,459
• Locations: 10
• Arms: 4
• Actual Duration (Months): 58.2
• Patients Per Site: 1545.9
• Patients Per Site Per Month: 26.6

Study Details

Study Description

Brief Summary

The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Biological: Malaria Vaccine 257049; Biological: Meningococcal C Conjugate Vaccine; Biological: Cell-culture rabies vaccine; Biological: TritanrixHepB/Hib; Biological: Polio Sabin Oral Polio Vaccine (GSK)	Phase 3

Detailed Description

The protocol posting document has been updated due to a protocol amendment dated 23 January 2012. An analysis time point has been added at Month 20. No changes have been made to the protocol endpoints or statistical methods but protocol endpoints will be analysed on data collected up to Month 20 once these data are available. The rationale is to have the full scope of protocol defined efficacy and safety endpoints related to a primary schedule without booster in both age categories followed up for 20 months earlier than at the initially planned study end time point (Visit 34 or Month 32 time point).

The protocol posting document was updated due to a protocol amendment dated 10 December 2010 to extend the study until December 2013 for all enrolled subjects (interval: Nov 2013-Jan 2014). Including the extension, the mean follow-up time for subjects from 5-17 months will be during 49 months post dose 1 (range: 41-55), while for subjects from 6-12 weeks, it will be during 41 months post dose 1 (range: 32-48). This study is double-blind during the first part and single-blind during the extension part. An analysis will be conducted at the end of the extension including an evaluation of safety and efficacy against clinical malaria, severe malaria and prevalent parasitemia.

The protocol posting document has been updated following the posting of results of the study (January 2015): The study remained double-blind until the end of the extension phase, and the analyses of Month 32 (initial end of study now becoming end of the first part of the study or primary study phase) and of the extension phase were conducted together.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15459 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. Falciparum Infection in Infants and Children in Africa
• Actual Study Start Date: Mar 27, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Jan 31, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Malaria Vaccine 257049; administered intramuscularly into the left deltoid.; Biological: Meningococcal C Conjugate Vaccine; administered intramuscularly into the left deltoid.; Other Names: Menjugate
Experimental: 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 interolateral 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.	Biological: Malaria Vaccine 257049; administered intramuscularly into the left deltoid.; Biological: Meningococcal C Conjugate Vaccine; administered intramuscularly into the left deltoid.; Other Names: Menjugate ; Biological: TritanrixHepB/Hib; administered intramuscularly into the left deltoid.; Biological: Polio Sabin Oral Polio Vaccine (GSK); administered orally.
Active Comparator: 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.	Biological: Meningococcal C Conjugate Vaccine; administered intramuscularly into the left deltoid.; Other Names: Menjugate ; Biological: Cell-culture rabies vaccine; administered intramuscularly into the left deltoid.; Other Names: VeroRab
Experimental: 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.	Biological: Meningococcal C Conjugate Vaccine; administered intramuscularly into the left deltoid.; Other Names: Menjugate ; Biological: TritanrixHepB/Hib; administered intramuscularly into the left deltoid.; Biological: Polio Sabin Oral Polio Vaccine (GSK); administered orally.

Outcome Measures

Primary Outcome Measures

1. 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) [From Month 2.5 to Month 14]

   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.

2. Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) [From Month 2.5 to Month 14]

   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.

Secondary Outcome Measures

1. 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 [From Month 2.5 to Month 14]

   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.

2. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center [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.

3. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of SCD1, SCD2 and SCD3 (Overall) [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.

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

5. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1), Across Centers [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.

6. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), Across Centers [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.

7. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD and SCD1, Across Centers [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.

8. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers [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.

9. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1) [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).

10. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1) [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).

11. Percentage of Subjects With Severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, Across Centers [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)]

    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.

12. Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 [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.

13. Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 [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.

14. Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1 [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.

15. Percentage of Subjects With Incident Severe Anaemia (ISA) and Malaria Hospitalization (MH) for Case Definitions (CD) Considered [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.

16. Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered [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.

17. Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered [From Month 2.5 to Month 32]

    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.

18. Percentage of Subjects With Prevalent Parasitemia, Prevalent Gametocytemia and Prevalent Severe and Moderate Anemia [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.

19. Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia [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).

20. Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed [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).

21. Percentage of Subjects With Fatal Malaria (FM) and All-cause Mortality (ACM) as Per Case Definitions Assessed [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.

22. Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed [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.

23. Percentage of Subjects With Blood Transfusion, as Per Case Definition Assessed [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.

24. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Gender and Overall [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.

25. Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) [At Month 20 (Booster)]

    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.

26. Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ) [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)]

    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.

27. Antibody Concentrations Against Plasmodium Falciparum Circumsporozoite (Anti-CS) [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.

28. Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) [At Day 0 and 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 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.

29. Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) [At Months 20, 21 and 32]

    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.

30. Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS) [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)]

    Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results for this endpoint were assessed for Agogo, Lilongwe and Siaya sites.

31. Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile [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.

32. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile [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.

33. Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile [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.

34. Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile [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.

35. Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) [At Day 0 and at Month 3]

    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.

36. Antibody Concentrations Against Hepatitis B Surface Antigen [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.

37. Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs) [At Months 20 and 21]

    Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 6.2 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.

38. Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3 [At Day 0 and at Month 3]

    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.

39. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses]

    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.

40. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses]

    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.

41. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [During the 7-day (Days 0-6) post-booster vaccination period]

    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.

42. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [During the 7-day (Days 0-6) post-booster vaccination period]

    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.

43. Number of Doses With Seizures by Diagnostic Certainty Level [During the 7-day (Days 0-6) post-booster vaccination period, at Month 20 + 7 Day (Days 0-6)]

    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.

44. Number of Subjects Reporting Mucocutaneous Changes (All Levels) [During the 30-day (Days 0-29) post-booster vaccination]

    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).

45. Number of Subjects Reporting Any Meningitis and Encephalitis Serious Adverse Events (SAEs) [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)]

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

46. Number of Subjects Reporting Any Meningitis and Encephalitis SAEs [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)]

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

47. Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) [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)]

    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.

48. Number of Subjects With Any Unsolicited Adverse Events (AEs) [Within the 30-day (Days 0-29) post-primary vaccination period]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.

49. Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal [Within the 30-day (Days 0-29) post-primary vaccination period]

    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 first 200 subjects enrolled in each study center.

50. Number of Subjects With Any Unsolicited AEs [Within the 30-day (days 0-29) post-booster vaccination period]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.

51. Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal [Within the 30-day (Days 0-29) post-primary and post-booster vaccination period in HIV-infected children]

    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).

52. Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal in the Low-weight (LW) and Very Low-weight (VLW) Category [Within the 30-day (Days 0-29) post-primary vaccination period in HIV-infected children]

    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). 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.

53. Number of Subjects With Unsolicited AEs Related to Vaccination in the Low-weight (LW) and Very Low-weight (VLW) Category [Within the 30-day (Days 0-29) post-booster vaccination period]

    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.

54. Number of Subjects With Serious Adverse Events (SAEs) [From Month 0 up to Month 14]

    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.

55. Number of Subjects With Serious Adverse Events (SAEs) [During the 30-day (Days 0-29) post-primary vaccination period]

    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.

56. Number of Subjects With Serious Adversee Events (SAEs) [From Month 0 up to Month 20]

    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.

57. Number of Subjects With Serious Adverse Events (SAEs) [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)]

    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.

58. Number of Subjects With Serious Adverse Events (SAEs) [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)]

    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.

59. Number of Subjects With Serious Adverse Events (SAEs) [Within the 30-day (Days 0-29) post-booster vaccination period]

    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.

60. Number of Subjects With Serious Adverse Events (SAEs) [From Month 0 up to Booster (Month 20), from Month 0 up to study end and from Month 20 up to study end]

    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.

61. Number of Low-weight (LW) Subjects With Serious Adverse Events (SAEs) [From Month 0 up to Month 20]

    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.

62. Number of Low-weight (LW) Subjects With Serious Adverse Events (SAEs) [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)]

    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.

63. Number of Very Low-weight (VLW) Subjects With Serious Adverse Events (SAEs) [From Month 0 up to Month 20]

    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.

64. Number of Very Low-weight Subjects With Serious Adverse Events (SAEs) [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)]]

    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.

65. Number of Subjects With Fatal Outcomes, by Gender [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)]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks to 17 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

• A male or female child of:5-17 months (inclusive) of age at time of first vaccination,or between 6-12 weeks of age at time of first vaccination and NOT have already received a dose of vaccine against diphtheria, tetanus or pertussis or Hemophilus influenzae type B and must be > 28 days of age at screening.

• Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.

All subjects must satisfy the following criteria at the start of the extension phase:

• Subjects who were enrolled and who received at least one vaccine dose in the primary trial phase.

• Subjects who were present for Visit 35 on or before 30 September 2013.

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

• Acute disease at the time of enrollment.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.

• Anemia associated with clinical signs or symptoms of decompensation or hemoglobin ≥ 5.0 g/dL.

• Major congenital defects.

• History of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunizations.

• Children with a past history of a neurological disorder or atypical febrile seizure.

• Children with malnutrition requiring hospital admission.

• Children currently meeting the criteria for HIV disease of Stage III or Stage IV severity as defined by the World Health Organization.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to a drug or vaccine that is not licensed for that indication with the exception of studies with the objective of improving the drug treatment or clinical management of severe malaria disease.

• Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Previous participation in any other malaria vaccine trial.

• Receipt of a vaccine within the preceding 7 days.

• Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

• Any other findings that the investigator feels would result in data collected being incomplete or of poor quality

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Ouagadougou		Burkina Faso
2	GSK Investigational Site	Lambaréné		Gabon
3	GSK Investigational Site	Kintampo		Ghana
4	GSK Investigational Site	Kumasi		Ghana
5	GSK Investigational Site	Kilifi		Kenya	80108
6	GSK Investigational Site	Kisumu		Kenya
7	GSK Investigational Site	Lilongwe		Malawi
8	GSK Investigational Site	Maputo		Mozambique
9	GSK Investigational Site	Dar-es-Salaam		Tanzania
10	GSK Investigational Site	Tanga		Tanzania

Sponsors and Collaborators

• GlaxoSmithKline
• The PATH Malaria Vaccine Initiative (MVI)

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Leach A, Vekemans J, Lievens M, Ofori-Anyinam O, Cahill C, Owusu-Agyei S, Abdulla S, Macete E, Njuguna P, Savarese B, Loucq C, Ballou WR; Clinical Trials Partnership Committee. Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa. Malar J. 2011 Aug 4;10:224. doi: 10.1186/1475-2875-10-224.
• Lievens M, Aponte JJ, Williamson J, Mmbando B, Mohamed A, Bejon P, Leach A. Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS, S/AS01 malaria vaccine in African children. Malar J. 2011 Aug 4;10:222. doi: 10.1186/1475-2875-10-222.
• Neafsey DE, Juraska M, Bedford T, Benkeser D, Valim C, Griggs A, Lievens M, Abdulla S, Adjei S, Agbenyega T, Agnandji ST, Aide P, Anderson S, Ansong D, Aponte JJ, Asante KP, Bejon P, Birkett AJ, Bruls M, Connolly KM, D'Alessandro U, Dobaño C, Gesase S, Greenwood B, Grimsby J, Tinto H, Hamel MJ, Hoffman I, Kamthunzi P, Kariuki S, Kremsner PG, Leach A, Lell B, Lennon NJ, Lusingu J, Marsh K, Martinson F, Molel JT, Moss EL, Njuguna P, Ockenhouse CF, Ogutu BR, Otieno W, Otieno L, Otieno K, Owusu-Agyei S, Park DJ, Pellé K, Robbins D, Russ C, Ryan EM, Sacarlal J, Sogoloff B, Sorgho H, Tanner M, Theander T, Valea I, Volkman SK, Yu Q, Lapierre D, Birren BW, Gilbert PB, Wirth DF. Genetic Diversity and Protective Efficacy of the RTS,S/AS01 Malaria Vaccine. N Engl J Med. 2015 Nov 19;373(21):2025-2037. doi: 10.1056/NEJMoa1505819. Epub 2015 Oct 21.
• RTS,S Clinical Trials Partnership, Agnandji ST, Lell B, Fernandes JF, Abossolo BP, Methogo BG, Kabwende AL, Adegnika AA, Mordmüller B, Issifou S, Kremsner PG, Sacarlal J, Aide P, Lanaspa M, Aponte JJ, Machevo S, Acacio S, Bulo H, Sigauque B, Macete E, Alonso P, Abdulla S, Salim N, Minja R, Mpina M, Ahmed S, Ali AM, Mtoro AT, Hamad AS, Mutani P, Tanner M, Tinto H, D'Alessandro U, Sorgho H, Valea I, Bihoun B, Guiraud I, Kaboré B, Sombié O, Guiguemdé RT, Ouédraogo JB, Hamel MJ, Kariuki S, Oneko M, Odero C, Otieno K, Awino N, McMorrow M, Muturi-Kioi V, Laserson KF, Slutsker L, Otieno W, Otieno L, Otsyula N, Gondi S, Otieno A, Owira V, Oguk E, Odongo G, Woods JB, Ogutu B, Njuguna P, Chilengi R, Akoo P, Kerubo C, Maingi C, Lang T, Olotu A, Bejon P, Marsh K, Mwambingu G, Owusu-Agyei S, Asante KP, Osei-Kwakye K, Boahen O, Dosoo D, Asante I, Adjei G, Kwara E, Chandramohan D, Greenwood B, Lusingu J, Gesase S, Malabeja A, Abdul O, Mahende C, Liheluka E, Malle L, Lemnge M, Theander TG, Drakeley C, Ansong D, Agbenyega T, Adjei S, Boateng HO, Rettig T, Bawa J, Sylverken J, Sambian D, Sarfo A, Agyekum A, Martinson F, Hoffman I, Mvalo T, Kamthunzi P, Nkomo R, Tembo T, Tegha G, Tsidya M, Kilembe J, Chawinga C, Ballou WR, Cohen J, Guerra Y, Jongert E, Lapierre D, Leach A, Lievens M, Ofori-Anyinam O, Olivier A, Vekemans J, Carter T, Kaslow D, Leboulleux D, Loucq C, Radford A, Savarese B, Schellenberg D, Sillman M, Vansadia P. A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. N Engl J Med. 2012 Dec 13;367(24):2284-95. doi: 10.1056/NEJMoa1208394. Epub 2012 Nov 9.
• RTS,S Clinical Trials Partnership, Agnandji ST, Lell B, Soulanoudjingar SS, Fernandes JF, Abossolo BP, Conzelmann C, Methogo BG, Doucka Y, Flamen A, Mordmüller B, Issifou S, Kremsner PG, Sacarlal J, Aide P, Lanaspa M, Aponte JJ, Nhamuave A, Quelhas D, Bassat Q, Mandjate S, Macete E, Alonso P, Abdulla S, Salim N, Juma O, Shomari M, Shubis K, Machera F, Hamad AS, Minja R, Mtoro A, Sykes A, Ahmed S, Urassa AM, Ali AM, Mwangoka G, Tanner M, Tinto H, D'Alessandro U, Sorgho H, Valea I, Tahita MC, Kaboré W, Ouédraogo S, Sandrine Y, Guiguemdé RT, Ouédraogo JB, Hamel MJ, Kariuki S, Odero C, Oneko M, Otieno K, Awino N, Omoto J, Williamson J, Muturi-Kioi V, Laserson KF, Slutsker L, Otieno W, Otieno L, Nekoye O, Gondi S, Otieno A, Ogutu B, Wasuna R, Owira V, Jones D, Onyango AA, Njuguna P, Chilengi R, Akoo P, Kerubo C, Gitaka J, Maingi C, Lang T, Olotu A, Tsofa B, Bejon P, Peshu N, Marsh K, Owusu-Agyei S, Asante KP, Osei-Kwakye K, Boahen O, Ayamba S, Kayan K, Owusu-Ofori R, Dosoo D, Asante I, Adjei G, Adjei G, Chandramohan D, Greenwood B, Lusingu J, Gesase S, Malabeja A, Abdul O, Kilavo H, Mahende C, Liheluka E, Lemnge M, Theander T, Drakeley C, Ansong D, Agbenyega T, Adjei S, Boateng HO, Rettig T, Bawa J, Sylverken J, Sambian D, Agyekum A, Owusu L, Martinson F, Hoffman I, Mvalo T, Kamthunzi P, Nkomo R, Msika A, Jumbe A, Chome N, Nyakuipa D, Chintedza J, Ballou WR, Bruls M, Cohen J, Guerra Y, Jongert E, Lapierre D, Leach A, Lievens M, Ofori-Anyinam O, Vekemans J, Carter T, Leboulleux D, Loucq C, Radford A, Savarese B, Schellenberg D, Sillman M, Vansadia P. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med. 2011 Nov 17;365(20):1863-75. doi: 10.1056/NEJMoa1102287. Epub 2011 Oct 18.
• RTS,S Clinical Trials Partnership. Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial. Lancet. 2015 Jul 4;386(9988):31-45. doi: 10.1016/S0140-6736(15)60721-8. Epub 2015 Apr 23. Erratum in: Lancet. 2015 Jul 4;386(9988):30.
• RTS,S Clinical Trials Partnership. Efficacy and safety of the RTS,S/AS01 malaria vaccine during 18 months after vaccination: a phase 3 randomized, controlled trial in children and young infants at 11 African sites. PLoS Med. 2014 Jul 29;11(7):e1001685. doi: 10.1371/journal.pmed.1001685. eCollection 2014 Jul.
• Swysen C, Vekemans J, Bruls M, Oyakhirome S, Drakeley C, Kremsner P, Greenwood B, Ofori-Anyinam O, Okech B, Villafana T, Carter T, Savarese B, Duse A, Reijman A, Ingram C, Frean J, Ogutu B; Clinical Trials Partnership Committee. Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine. Malar J. 2011 Aug 4;10:223. doi: 10.1186/1475-2875-10-223.
• Vandoolaeghe P, Schuerman L. The RTS,S/AS01 malaria vaccine in children 5 to 17 months of age at first vaccination. Expert Rev Vaccines. 2016 Dec;15(12):1481-1493. Review.
• Vekemans J, Marsh K, Greenwood B, Leach A, Kabore W, Soulanoudjingar S, Asante KP, Ansong D, Evans J, Sacarlal J, Bejon P, Kamthunzi P, Salim N, Njuguna P, Hamel MJ, Otieno W, Gesase S, Schellenberg D; Clinical Trials Partnership Committee. Assessment of severe malaria in a multicenter, phase III, RTS, S/AS01 malaria candidate vaccine trial: case definition, standardization of data collection and patient care. Malar J. 2011 Aug 4;10:221. doi: 10.1186/1475-2875-10-221.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00866619
• Other Study ID Numbers: 110021; 2012-005716-26
• First Posted: Mar 20, 2009
• Last Update Posted: Oct 9, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Malaria; Vaccines

Study Results

Participant Flow

Recruitment Details	The study included 3 phases, a primary (PRI) phase (Months 0-3) and a booster (BST) phase at Month 20, each followed by a related PRI/BST efficacy, immunogenicity and safety (EIS) follow-up (FU) phase, and an EIS extension, from Month 32 to the median of Month 48 or Month 38 time point.
Pre-assignment Detail	Screening included the following: check for inclusion/exclusion criteria, vaccination contraindications/precautions, subjects' medical history and signing informed consent forms.

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

Baseline Characteristics

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group	Total
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Total of all reporting groups
Overall Participants	5948	4358	2974	2179	15459
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	10.6 (3.8)	1.2 (0.4)	10.6 (3.7)	1.2 (0.4)	6.6 (5.5)
Sex: Female, Male (Count of Participants)
Female	2967 49.9%	2124 48.7%	1503 50.5%	1100 50.5%	7694 49.8%
Male	2981 50.1%	2234 51.3%	1471 49.5%	1079 49.5%	7765 50.2%
Race/Ethnicity, Customized (Count of Participants)
African heritage/African American	5948 100%	4358 100%	2974 100%	2179 100%	15459 100%

Outcome Measures

1. Primary Outcome

Title	Rate of First or Only Clinical Episode of Plasmodium Falciparum (P. Falciparum) Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD)
Description	A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia was greater than (>) 5000 parasites per microliter (µL) accompanied by the presence of fever [axillary temperature greater than or equal to (≥) 37.5°C] at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 5-17 months age category.
Time Frame	From Month 2.5 to Month 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	VeroRab Comparator [5-17M] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.
Measure Participants	2830	1466
Number [events per person-year]	0.435	0.833

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK257049 [5-17M] Group, VeroRab Comparator [5-17M] Group
	Comments	The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus [Hazard Ratio (HR) in GSK257049 [5-17M] Group (HR1) divided by HR in control VeroRab Comparator [5-17M] Group (HR2)]; i. e. 1 - (HR1/HR2).
	Type of Statistical Test	Superiority
	Comments	Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	55.8
	Confidence Interval	(2-Sided) 97.5%; 50.6 to 60.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD)
Description	A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia > 5000 parasites/µL was accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is, person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 6-12 weeks (6-12W) age category.
Time Frame	From Month 2.5 to Month 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	3995	2008
Number [events per person-year]	0.367	0.484

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK257049 [5-17M] Group, VeroRab Comparator [5-17M] Group
	Comments	The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus [Hazard Ratio (HR) in GSK257049 [6-12W] Group (HR1) divided by HR in control Menjugate Comparator [6-12W] Group (HR2)]; i. e. 1 - (HR1/HR2).
	Type of Statistical Test	Superiority
	Comments	Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Vaccine efficacy
	Estimated Value	31.315
	Confidence Interval	(2-Sided) 97.5%; 23.556 to 38.286
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Rate of All Episodes of P. Falciparum Clinical Malaria Infection (CPFMI) of PCD and of Secondary Case Definitions (SCD) 1, SCD 2 and SCD 3
Description	PCD=malaria episode with P. falciparum asexual parasitemia (PFAP) > 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease. SCD1=malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2=malaria episode with PFAP > 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3=malaria episode with PFAP > 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
Time Frame	From Month 2.5 to Month 14

Outcome Measure Data

Analysis Population Description

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

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

4. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, Overall and by Center
Description	PCD = malaria episode with PFAP > 5000 parasites/µL accompanied by fever and occurring in a child unwell brought for treatment to a healthcare facility or a case of malaria meeting the PCD of severe malaria disease (see below endpoints on severe malaria for details). Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are by center and across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
Time Frame	From Month 2.5 to Month 20

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.

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

5. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of SCD1, SCD2 and SCD3 (Overall)
Description	SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. SCD2 = malaria episode with PFAP > 500 parasites/μL and fever at time of presentation in a subject unwell brought for treatment to a healthcare facility. SCD3 = malaria episode with PFAP > 20.000 parasites/μL and fever at time of presentation in a subject unwell and brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are across centers, and are uncorrected for double enrollment of 1 subject receiving GSK257049 vaccine.
Time Frame	From Month 2.5 to Month 20

Outcome Measure Data

Analysis Population Description

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

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

6. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Centers and Across Centers
Description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.
Time Frame	From Month 2.5 up to study End (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.

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

7. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1), Across Centers
Description	CPFMI of SCD1 = malaria episode with PFAP >0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
Time Frame	From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

Outcome Measure Data

Analysis Population Description

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

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

8. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1), Across Centers
Description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP >0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
Time Frame	From Booster at Month 20 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

Outcome Measure Data

Analysis Population Description

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

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

9. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD and SCD1, Across Centers
Description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented across centers.
Time Frame	From Month 33 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

Outcome Measure Data

Analysis Population Description

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

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

10. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of PCD, by Center and Across Centers
Description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all CPFMI episodes is expressed as person-year rate in each group (n/T). Results are presented by center and across centers.
Time Frame	From Month 2.5 to Month 32

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 5-17M groups for the Manhica site.

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

11. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Secondary Case Definition 1 (SCD1)
Description	CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).
Time Frame	From Month 2.5 to Month 32

Outcome Measure Data

Analysis Population Description

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

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

12. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD) and Secondary Case Definition 1 (SCD1)
Description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. CPFMI of SCD1 = malaria episode with PFAP > 0 and fever at time of presentation or history of fever within 24h of presentation in a subject unwell brought for treatment to a healthcare facility. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T).
Time Frame	From Booster at Month 20 up to Month 32

Outcome Measure Data

Analysis Population Description

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

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

13. Secondary Outcome

Title	Percentage of Subjects With Severe PFMI (SPFMI) of PCD, SCD1, SCD2 and SCD3, Across Centers
Description	SPFMI of PCD = PFMI > 5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. SPFMI of SCD2 = PFMI >0 with one or more severity marker and without co-morbidity diagnosis. SPFMI of SCD3 = PFMI >5000 parasites/μL, with one or more severity marker, and without co-morbidity or HIV. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia < 2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l < 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. Analysis was performed in a pooled manner across age categories. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
Time Frame	From Month 2.5 up to the time when 250 subjects were diagnosed with severe malaria of PCD, SCD1, SCD2 and SCD3 (up to the Month 14 time point for each age category or date of booster dose, whichever occurred first)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 Group	Comparator Group
Arm/Group Description	For the purpose of the analysis, GSK257049 [5-17M] and GSK257049 [6-12W] groups have been pooled into a single group.	For the purpose of the analysis, VeroRab Comparator [5-17M] and Menjugate Comparator [6-12W] groups have been pooled into a single group.
Measure Participants	8597	4364
PCD	0.019	0.03
SCD1	0.023	0.036
SCD2	0.023	0.034
SCD3	0.019	0.03

14. Secondary Outcome

Title	Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1
Description	SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.
Time Frame	From Month 2.5 to Month 14

Outcome Measure Data

Analysis Population Description

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

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

15. Secondary Outcome

Title	Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1
Description	SPFMI of PCD = PFMI>5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI>5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category.
Time Frame	From Month 2.5 to Month 20 at Booster

Outcome Measure Data

Analysis Population Description

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

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

16. Secondary Outcome

Title	Percentage of Subjects With Severe PFMI (SPFMI) of PCD and SCD1
Description	SPFMI of PCD = PFMI >5000 parasites/μL, at least one severity marker and no co-morbidity diagnosis. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL. Comorbidities = radiographically proven pneumonia; meningitis; positive blood culture on a blood culture taken within 72 h of admission; gastroenteritis with dehydration. SPFMI of SCD1 = PFMI >5000 parasites/μL and with one or more severity marker. Severity markers = prostration; respiratory distress; Blantyre score ≤ 2; ≥ 2 seizures in 24 h prior to admission, emergency room and hospitalisation; hypoglycaemia<2.2 mmol/L; acidosis BE ≤ -10.0 mmol/L,l ≥ 5.0 mmol/L; anaemia<5.0 g/dL.
Time Frame	From Month 2.5, from Month 20(booster), from Month 33 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17M age category and of 38 months post-Dose 1 for 6-12W age category) and from Month 2.5 to Month 32 and from Month 20 to Month 32

Outcome Measure Data

Analysis Population Description

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

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

17. Secondary Outcome

Title	Percentage of Subjects With Incident Severe Anaemia (ISA) and Malaria Hospitalization (MH) for Case Definitions (CD) Considered
Description	CD considered were CD1 for ISA and CD1 and CD2 for MH. ISA of CD1 was defined as a documented hemoglobin < 5.0 g/dL identified at clinical presentation to morbidity surveillance system in association with a P. falciparum parasitemia > 5000 parasites/μL. MH of CD1 was defined as a medical hospitalization with confirmed P. falciparum > 5000 parasites/μL. MH of CD2 was defined as a hospitalization which, in the judgment of the principal investigator, P. falciparum infection was the sole or a major contributing factor to the presentation. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
Time Frame	From Month 2.5 to Month 20

Outcome Measure Data

Analysis Population Description

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

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

18. Secondary Outcome

Title	Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered
Description	ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.
Time Frame	From Month 2.5 to up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

Outcome Measure Data

Analysis Population Description

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

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

19. Secondary Outcome

Title	Percentage of Subjects With Incident Severe Anaemia (ISA), Malaria Hospitalization (MH) and Fatal Malaria (FM) for Case Definitions (CD) Considered
Description	ISA CD considered were CD1, CD2 and CD3 (definitions mentioned in the previous outcome measure). MH CD considered were CD1 and CD2 (definitions mentioned in the previous outcome measure).FM CD considered were primary CD (PCD) and sedondary CDs 1 and 4 (SCD1 and SCD4). FM of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease with a fatal outcome. FM of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease with a fatal outcome. FM of SCD4 was defined as a fatal case associated with International Classification Disease (ICD10) codes B50, B53 and/or B54. Code B50 corresponds to P. falciparum malaria including mixed infections of P. falciparum with any other Plasmodium species; Code B53 corresponds to other parasitologically confirmed malaria; Code B54 corresponds to unspecified malaria including clinically diagnosed malaria without parasitological confirmation.
Time Frame	From Month 2.5 to Month 32

Outcome Measure Data

Analysis Population Description

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

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

20. Secondary Outcome

Title	Percentage of Subjects With Prevalent Parasitemia, Prevalent Gametocytemia and Prevalent Severe and Moderate Anemia
Description	Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent gametocytemia (PG) was defined as a documented P. falciparum gametocyte density > 0 identified at a cross sectional survey. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at at timing of assessment. Results presented are uncorrected for the double enrollment of one subject receiving RTS,S/AS01.
Time Frame	At Month 20 (Booster)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period starting 14 days post Dose 3. Data was not collected for the participants in the 6-12W groups for the PG category.

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

21. Secondary Outcome

Title	Percentage of Subjects With Prevalent Parasitemia and Prevalent Severe and Moderate Anemia
Description	Prevalent parasitemia (PP) was defined as a documented P. falciparum asexual parasite density > 0 identified at timing of assessment. Prevalent severe anemia (PSA) was defined as a documented hemoglobin < 5.0 g/dL identified at timing of assessment. Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL identified at timing of assessment. Analysis was performed on subjects aged 5-17 months at enrollment. Study End (Early) corresponds to children whose Month 32 visit took place after 30 June 2012 and who had one cross-sectional visit at study end. These children's last study visit was relatively earlier, with a median follow-up time of 14 months post Month 32. Study End (Late) corresponds to children whose Month 32 visit took place before (and including) 30 June 2012, and who had 2 cross-sectional visits after Month 32. These children's last study visit was relatively later, with a median follow-up time of 17 months post Month 32).
Time Frame	At Months 32, 44, at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category) (early and late)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP population for efficacy, which included all children who received all vaccinations according to protocol procedures and contributed to the time at risk in the follow-up period 14 days post Dose 3. Data was not collected for the participants in the 6-12W groups for the PP, PSA, PMA categories at M44, SE (Late).

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

22. Secondary Outcome

Title	Percentage of Subjects With Pneumonia, All-cause Hospitalization and Sepsis, as Per Case Definitions Assessed
Description	Pneumonia case definitions assessed are PCD and SCD 1, 2 and 3. Pneumonia of PCD was defined as cough or difficulty breathing AND tachypnea (≥ 50 breaths per minute < 1 year, ≥ 40 breaths per minute ≥ 1year) AND lower chest wall indrawing. Pneumonia of SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission. Pneumonia of SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission. Pneumonia of SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation < 90%. All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excludes planned admissions for medical investigation/care or elective surgery and trauma). Sepsis cases were defined as a child with positive blood culture (CD1) or salmonella blood culture (CD2).
Time Frame	From Month 2.5 to Month 20

Outcome Measure Data

Analysis Population Description

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

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

23. Secondary Outcome

Title	Percentage of Subjects With Fatal Malaria (FM) and All-cause Mortality (ACM) as Per Case Definitions Assessed
Description	Fatal malaria case definitions assessed were PCD and SCD1. Fatal malaria of PCD was defined as a case of severe malaria meeting the primary case definition of severe malaria disease (defined in a previous outcome measure) with a fatal outcome. Fatal malaria of SCD1 was defined as a case of severe malaria meeting the secondary case definition 1 severe malaria disease (defined previously) with a fatal outcome. All-cause mortality case definitions assessed were the case definitions (CD) 1 and 2. All-cause mortality of CD1 was defined as a fatality (of any cause) (including mortality in the community and in hospital). All-cause mortality of CD2 was defined as a fatality (medical cause) (including mortality in the community and in hospital), at the exclusion of trauma which may be diagnosed by verbal autopsy. Results presented are uncorrected for double enrollment of one subject in 5-17 months age category receiving GSK257049 vaccine.
Time Frame	From Month 2.5 to Month 20

Outcome Measure Data

Analysis Population Description

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

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

24. Secondary Outcome

Title	Percentage of Subjects With Pneumonia, All-cause Hospitalization/Mortality and Sepsis, as Per Case Definitions Assessed
Description	Pneumonia of PCD was defined as cough or difficulty breathing (on history) AND tachypnea (>= 50 breaths per minute < 1 year, >= 40 breaths per minute >= 1year) AND lower chest wall indrawing,SCD1 was defined as pneumonia of PCD accompanied by chest X-ray (CXR) consolidation or pleural effusion on x-ray taken within 72 h of admission,SCD2 was defined as pneumonia of PCD accompanied by consolidation or pleural effusion or other infiltrates on a chest x-ray taken within 72 h of admission,SCD3 was defined as pneumonia of PCD accompanied by an oxygen saturation less than 90%.All-cause hospitalization of PCD was defined as a medical hospitalization of any cause (excluding planned admissions for medical investigation/care or elective surgery and trauma).All-cause mortality of CD1 was defined as a fatality (of any cause),of CD2 defined as a fatality (medical cause).Sepsis of CD1 was defined as a child with positive blood culture;CD2 defined as a child with positive salmonella blood culture.
Time Frame	From Month 2.5 up to study end (with a median follow-up time post-Dose 1 of 48 months for 5-17M groups and 38 months for 6-12W groups)

Outcome Measure Data

Analysis Population Description

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

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

25. Secondary Outcome

Title	Percentage of Subjects With Blood Transfusion, as Per Case Definition Assessed
Description	Blood transfusion case definition assessed was the case definition 1 (CD1). Blood transfusion of CD1 was defined as a child with inpatient admission with documented blood transfusion.
Time Frame	From Month 2.5 up to study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Outcome Measure Data

Analysis Population Description

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

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

26. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Gender and Overall
Description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by the presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). Analysis was performed on subjects aged 5-17 months and 6-12 weeks at enrollment. Results were presented by gender and overall.
Time Frame	From Month 2.5 to Month 32

Outcome Measure Data

Analysis Population Description

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

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

27. Secondary Outcome

Title	Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ)
Description	Anthropometry consisted of length/height for age z-score [HAZ] (children < 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score [WAZ] and mid-upper arm circumference for age z-score [MUACZ] measurements, where a HAZ < -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ > -3 and ≤ -2 z-score indicates a low weight for age, a WAZ > - 2 z-score indicates normal weight. A MUACZ < -2 z-score indicates children that are wasted, a MUACZ < - 3 z-score indicates severely wasted children.
Time Frame	At Month 20 (Booster)

Outcome Measure Data

Analysis Population Description

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

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

28. Secondary Outcome

Title	Height, Weight and Mid Upper Arm Circumference for Age Z-score (HAZ, WAZ and MUACZ)
Description	Anthropometry consisted of length/height for age z-score [HAZ] (children < 2 years length measure and children ≥ 2 years standing height measure), weight for age z-score [WAZ] and mid-upper arm circumference for age z-score [MUACZ] measurements, where a HAZ < -1,5 z-score, indicates growth deficit, while a HAZ between -1,0 and ± 1,0 z-score, indicates normal height. A WAZ ≤ -3 z-score indicates a very low weight for age, a WAZ > -3 and ≤ -2 z-score indicates a low weight for age, a WAZ > - 2 z-score indicates normal weight. A MUACZ < -2 z-score indicates children that are wasted, a MUACZ < - 3 z-score indicates severely wasted children. Note: The early study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end and to late study end refers to children whose last visit in the primary study phase (Month 32) was after 30 June 2012 and who by protocol had one cross-sectional study end.
Time Frame	At Months 32, 44, at study end (early and late) (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Outcome Measure Data

Analysis Population Description

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

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

29. Secondary Outcome

Title	Antibody Concentrations Against Plasmodium Falciparum Circumsporozoite (Anti-CS)
Description	Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 subjects enrolled in each study center.
Time Frame	At Day 0 and at Month 3

Outcome Measure Data

Analysis Population Description

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

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

30. Secondary Outcome

Title	Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)
Description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.
Time Frame	At Day 0 and at Month 3

Outcome Measure Data

Analysis Population Description

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

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

31. Secondary Outcome

Title	Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)
Description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL.
Time Frame	At Months 20, 21 and 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	442	438	426	530	569	554
Anti-CS, Agogo - Month 20	34.1	52.1	0.3	5.1	5.6	0.3
Anti-CS, Agogo - Month 21	265.0	48.3	0.3	137.6	5.3	0.3
Anti-CS, Agogo - Month 32	46.3	28.8	0.3	14.8	2.9	0.3
Anti-CS, Bagamoyo - Month 20	26.6	23.1	0.3	6.9	7.6	0.3
Anti-CS, Bagamoyo - Month 21	306.6	31.8	0.6	169.9	7.2	0.3
Anti-CS, Bagamoyo - Month 32	44.6	16.9	0.3	14.4	3.7	0.3
Anti-CS, Kilifi - Month 20	34.3	33.1	0.3	6.6	6.1	0.3
Anti-CS, Kilifi - Month 21	308.4	24.3	0.3	229.3	5.3	0.3
Anti-CS, Kilifi - Month 32	59.4	14.9	0.3	19.8	2.8	0.3
Anti-CS, Kintampo - Month 20	50.8	36.6	0.4	3.8	3.7	0.3
Anti-CS, Kintampo - Month 21	266.8	41.2	0.3	128.8	3.2	0.3
Anti-CS, Kintampo - Month 32	70.9	20.2	0.4	13.3	2.2	0.3
Anti-CS, Kombewa - Month 20	39.8	46.6	0.3	5.5	8.7	0.4
Anti-CS, Kombewa - Month 21	308.5	37.1	0.4	146.3	9.2	0.4
Anti-CS, Kombewa - Month 32	53.8	19.8	0.3	8.3	4.3	0.4
Anti-CS, Korogwe - Month 20	29.4	28.2	0.3	7.9	8.1	0.3
Anti-CS, Korogwe - Month 21	305.6	27.1	0.3	178.3	7.6	0.3
Anti-CS, Korogwe - Month 32	47.4	16.8	0.3	19.6	4.9	0.3
Anti-CS, Lambarene - Month 20	8.2	11.1	0.3	7.7	8.3	0.3
Anti-CS, Lambarene - Month 21	203.6	10.6	0.3	251.3	7.4	0.3
Anti-CS, Lambarene - Month 32	23.0	5.9	0.3	21.0	4.1	0.3
Anti-CS, Lilongwe - Month 20	45.9	22.2	0.4	5.1	7.4	0.3
Anti-CS, Lilongwe - Month 21	285.0	17.0	0.3	126.1	8.0	0.3
Anti-CS, Lilongwe - Month 32	45.6	12.7	0.3	15.4	4.5	0.3
Anti-CS, Nanoro - Month 20	57.2	61.8	0.3	2.7	3.2	0.3
Anti-CS, Nanoro - Month 21	520.5	71.1	0.3	163.2	3.1	0.3
Anti-CS, Nanoro - Month 32	69.2	35.0	0.3	11.9	2.8	0.5
Anti-CS, Siaya - Month 20	28.4	32.8	0.3	7.0	8.9	0.4
Anti-CS, Siaya - Month 21	398.1	36.4	0.3	171.5	8.4	0.4
Anti-CS, Siaya - Month 32	55.8	21.7	0.4	23.6	5.5	0.5
Anti-CS, Manhica - Month 20	12.3	14.7	0.3
Anti-CS, Manhica - Month 21	260.2	12.3	0.3
Anti-CS, Manhica - Month 32	25.4	6.8	0.3
Anti-CS, Overall sites - Month 20	34.4	35.4	0.3	5.9	6.6	0.3
Anti-CS, Overall sites - Month 21	318.2	34.2	0.3	169.9	6.2	0.3
Anti-CS, Overall sites - Month 32	52.4	19.3	0.3	15.9	3.7	0.3

32. Secondary Outcome

Title	Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS)
Description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results for this endpoint were assessed for Agogo, Lilongwe and Siaya sites.
Time Frame	At Month 44 and at study end (median follow-up time of 48 months post-Dose 1 for 5-17 months age category and of 38 months post-Dose 1 for 6-12 weeks age category)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP population for immunogenicity, which included all first 200 children enrolled in each study center in each age category who received all vaccinations according to the protocol procedures. Data was not collected for the participants in the 6-12W groups at M44.

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	104	101	98	101	103	131
Anti-CS, Agogo - Month 44	27.7	17.9	0.3
Anti-CS, Agogo - Study end	23.2	17.2	0.3	6.1	2.1	0.3
Anti-CS, Lilongwe - Month 44	30.5	8.5	0.3
Anti-CS, Lilongwe - Study end	26.9	7.2	0.3	10.9	2.8	0.3
Anti-CS, Siaya - Month 44	41.4	21.2	0.5
Anti-CS, Siaya - Study end	27.4	15.8	0.4	10.4	3.3	0.4
Anti-CS, Overall - Month 44	33.0	16.8	0.3
Anti-CS, Overall - Study end	25.4	14.4	0.3	8.9	2.6	0.3

33. Secondary Outcome

Title	Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile
Description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - Menjugate [5-17M] Group	GSK257049 - Menjugate [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	545	639
Anti-CS, Tertile 1	264.15	78.45
Anti-CS, Tertile 2	613.79	230.68
Anti-CS, Tertile 3	1351.41	592.65
Anti-CS, Across Tertiles	603.77	220.9

34. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile
Description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post primary vaccination pooled across sites, on subjects in GSK257049-Menjugate Groups (5-17M; 6-12W) and Comparator Groups (5-17M; 6-12W), taking into account the first 200 participants per site.
Time Frame	From Month 2.5 to Month 32

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	182	565	214	677
Tertile 1	0.68	1.21	1.29	0.93
Tertile 2	0.78	1.21	0.7	0.93
Tertile 3	1.03	1.21	0.58	0.93

35. Secondary Outcome

Title	Antibody Concentrations Against P. Falciparum Circumsporozoite (Anti-CS), by Tertile
Description	Anti-CS antibody concentrations were determined by ELISA and presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. The seropositivity cut-off for the endpoint was a GMC value ≥ 0.5 EL.U/mL. Results were presented by tertiles of anti-CS responses in the first 200 participants per site, based on subjects assessed for vaccine efficacy results.
Time Frame	At Month 21

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	465	546
Anti-CS, Tertile 1	138.15	47.99
Anti-CS, Tertile 2	311.35	194.85
Anti-CS, Tertile 3	675.24	479.44
Anti-CS, Across Tertiles	307.93	165.31

36. Secondary Outcome

Title	Rate of All Episodes of Clinical P. Falciparum Malaria Infection (CPFMI) of Primary Case Definition (PCD), by Tertile
Description	CPFMI of PCD = episode of malaria for which PFAP > 5000 parasites/µL accompanied by presence of fever (axillary temperature ≥ 37.5°C at time of presentation) AND occurring in a child unwell brought for treatment to a healthcare facility OR a case of malaria meeting the PCD of severe malaria disease. Time to all episodes of CPFMI is expressed as a rate of all CPFMI (RaCPFMI), that is, person-year rate in each group (n/T). RaCPFMI was calculated by tertile of anti-CS response post booster vaccination pooled across sites, on subjects in R3R (5-17M; 6-12W) (or R3R below) and C3C (5-17M; 6-12W) (or C3C below) groups taking into account the first 200 participants per site.
Time Frame	From Booster at Month 20 to Month 32

Outcome Measure Data

Analysis Population Description

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

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

37. Secondary Outcome

Title	Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)
Description	Antibody concentrations assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.
Time Frame	At Day 0 and at Month 3

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	1029	1213	526	627
Anti-HBs, Day 0	166.3	8.6	168.6	8.5
Anti-HBs, Month 3	81567.7	13674.3	127.5	728.8

38. Secondary Outcome

Title	Antibody Concentrations Against Hepatitis B Surface Antigen
Description	Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 10 and 100 mIU/mL, respectively. Results were assessed for the first 200 HIV-infected subjects enrolled in each study center. HIV infection was confirmed if present at screening or identified by morbidity surveillance, not infection confirmed by antibody testing after 18 months of age or by PCR, by the time of the analysis of results up to the Month 14 time point for the respective 5-17 months and 6-12 weeks age categories.
Time Frame	At Day 0 and at Month 3

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	29	25	17	5
Anti-HBs, Day 0	98.6	7.5	63.6	5
Anti-HBs, Month 3	37476.5	1996.2	37.1	197.2

39. Secondary Outcome

Title	Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)
Description	Antibody concentrations as assessed by ELISA, were presented as geometric mean concentrations (GMCs), and expressed in mIU/mL. The seropositivity and seroprotection cut-offs were ≥ 6.2 and 100 mIU/mL, respectively. Results were assessed for the first 200 subjects in each center.
Time Frame	At Months 20 and 21

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	95	134
Anti-HBs, Month 20	5068.5	1532.5
Anti-HBs, Month 21	95206.4	116458.1

40. Secondary Outcome

Title	Antibody Titers Against Poliomyelitis (Anti-polio) Type 1, 2 and 3
Description	Anti-Polio 1, 2 and 3 antibody titers were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was an antibody titer ≥ 1:8.
Time Frame	At Day 0 and at Month 3

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	931	474
Anti-Polio 1, Day 0	47.4	43.3
Anti-Polio 1, Month 3	334.9	417.6
Anti-Polio 2, Day 0	38.6	40.3
Anti-Polio 2, Month 3	372.1	450.8
Anti-Polio 3, Day 0	9.4	9.1
Anti-Polio 3, Month 3	80.0	95.9

41. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Assessed solicited local symptoms included pain, redness and swelling. Any = the incidence of a particular symptom, regardless of intensity grade. Grade 3 pain = cried when limb was moved, spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time Frame	During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	1479	721	1462	738
Any Pain, Dose 1	247 4.2%	61 1.4%	435 14.6%	215 9.9%
Grade 3 Pain, Dose 1	0 0%	0 0%	10 0.3%	7 0.3%
Any Redness, Dose 1	66 1.1%	26 0.6%	176 5.9%	89 4.1%
Grade 3 Redness, Dose 1	2 0%	0 0%	3 0.1%	3 0.1%
Any Swelling, Dose 1	140 2.4%	77 1.8%	227 7.6%	125 5.7%
Grade 3 Swelling, Dose 1	6 0.1%	0 0%	27 0.9%	29 1.3%
Any Pain, Dose 2	179 3%	41 0.9%	383 12.9%	178 8.2%
Grade 3 Pain, Dose 2	3 0.1%	0 0%	5 0.2%	3 0.1%
Any Redness, Dose 2	26 0.4%	18 0.4%	124 4.2%	90 4.1%
Grade 3 Redness, Dose 2	3 0.1%	0 0%	3 0.1%	1 0%
Any Swelling, Dose 2	140 2.4%	50 1.1%	228 7.7%	128 5.9%
Grade 3 Swelling, Dose 2	15 0.3%	0 0%	29 1%	17 0.8%
Any Pain, Dose 3	108 1.8%	22 0.5%	345 11.6%	153 7%
Grade 3 Pain, Dose 3	0 0%	0 0%	8 0.3%	2 0.1%
Any Redness, Dose 3	42 0.7%	13 0.3%	113 3.8%	63 2.9%
Grade 3 Redness, Dose 3	2 0%	0 0%	1 0%	1 0%
Any Swelling, Dose 3	134 2.3%	35 0.8%	185 6.2%	111 5.1%
Grade 3 Swelling, Dose 3	9 0.2%	0 0%	9 0.3%	12 0.6%
Any Pain, Across doses	401 6.7%	105 2.4%	705 23.7%	342 15.7%
Grade 3 Pain, Across doses	3 0.1%	0 0%	23 0.8%	12 0.6%
Any Redness, Across doses	122 2.1%	49 1.1%	292 9.8%	163 7.5%
Grade 3 Redness, Across doses	6 0.1%	0 0%	7 0.2%	5 0.2%
Any Swelling, Across doses	303 5.1%	119 2.7%	427 14.4%	248 11.4%
Grade 3 Swelling, Across doses	25 0.4%	0 0%	59 2%	53 2.4%

42. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-primary vaccination period following each dose and across doses

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	1479	1462	721	738
Any Drowsiness, Dose 1	91 1.5%	164 3.8%	27 0.9%	65 3%
Grade 3 Drowsiness, Dose 1	3 0.1%	1 0%	0 0%	1 0%
Related Drowsiness, Dose 1	33 0.6%	88 2%	8 0.3%	26 1.2%
Any Irritability, Dose 1	165 2.8%	370 8.5%	41 1.4%	157 7.2%
Grade 3 Irritability, Dose 1	0 0%	10 0.2%	0 0%	3 0.1%
Related Irritability, Dose 1	64 1.1%	226 5.2%	16 0.5%	84 3.9%
Any Loss of appetite, Dose 1	202 3.4%	124 2.8%	71 2.4%	52 2.4%
Grade 3 Loss of appetite, Dose 1	3 0.1%	2 0%	0 0%	0 0%
Related Loss of appetite, Dose 1	71 1.2%	67 1.5%	24 0.8%	24 1.1%
Any Fever, Dose 1	385 6.5%	459 10.5%	108 3.6%	192 8.8%
Grade 3 Fever, Dose 1	29 0.5%	5 0.1%	7 0.2%	2 0.1%
Related Fever, Dose 1	200 3.4%	326 7.5%	52 1.7%	127 5.8%
Any Drowsiness, Dose 2	99 1.7%	135 3.1%	37 1.2%	55 2.5%
Grade 3 Drowsiness, Dose 2	1 0%	0 0%	0 0%	0 0%
Related Drowsiness, Dose 2	61 1%	74 1.7%	26 0.9%	15 0.7%
Any Irritability, Dose 2	192 3.2%	289 6.6%	45 1.5%	123 5.6%
Grade 3 Irritability, Dose 2	2 0%	7 0.2%	0 0%	0 0%
Related Irritability, Dose 2	114 1.9%	175 4%	28 0.9%	57 2.6%
Any Loss of appetite, Dose 2	151 2.5%	105 2.4%	47 1.6%	43 2%
Grade 3 Loss of appetite, Dose 2	0 0%	0 0%	0 0%	0 0%
Related Loss of appetite, Dose 2	89 1.5%	60 1.4%	24 0.8%	8 0.4%
Any Fever, Dose 2	503 8.5%	411 9.4%	100 3.4%	154 7.1%
Grade 3 Fever, Dose 2	42 0.7%	9 0.2%	10 0.3%	6 0.3%
Related Fever, Dose 2	267 4.5%	278 6.4%	42 1.4%	89 4.1%
Any Drowsiness, Dose 3	97 1.6%	124 2.8%	29 1%	44 2%
Grade 3 Drowsiness, Dose 3	1 0%	1 0%	0 0%	1 0%
Related Drowsiness, Dose 3	52 0.9%	49 1.1%	16 0.5%	19 0.9%
Any Irritability, Dose 3	138 2.3%	287 6.6%	27 0.9%	104 4.8%
Grade 3 Irritability, Dose 3	1 0%	3 0.1%	0 0%	2 0.1%
Related Irritability, Dose 3	76 1.3%	144 3.3%	15 0.5%	54 2.5%
Any Loss of appetite, Dose 3	138 2.3%	106 2.4%	40 1.3%	45 2.1%
Grade 3 Loss of appetite, Dose 3	2 0%	0 0%	0 0%	1 0%
Related Loss of appetite, Dose 3	76 1.3%	44 1%	18 0.6%	20 0.9%
Any Fever, Dose 3	457 7.7%	429 9.8%	77 2.6%	111 5.1%
Grade 3 Fever, Dose 3	39 0.7%	13 0.3%	7 0.2%	3 0.1%
Related Fever, Dose 3	262 4.4%	280 6.4%	32 1.1%	57 2.6%
Any Drowsiness, Across doses	230 3.9%	285 6.5%	78 2.6%	121 5.6%
Grade 3 Drowsiness, Across doses	5 0.1%	2 0%	0 0%	2 0.1%
Related Drowsiness, Across doses	121 2%	144 3.3%	44 1.5%	51 2.3%
Any Irritability, Across doses	369 6.2%	574 13.2%	96 3.2%	244 11.2%
Grade 3 Irritability, Across doses	3 0.1%	17 0.4%	0 0%	5 0.2%
Related Irritability, Across doses	207 3.5%	363 8.3%	54 1.8%	139 6.4%
Any Loss of appetite, Across doses	398 6.7%	243 5.6%	132 4.4%	104 4.8%
Grade 3 Loss of appetite, Across doses	5 0.1%	2 0%	0 0%	1 0%
Related Loss of appetite, Across doses	206 3.5%	128 2.9%	61 2.1%	41 1.9%
Any Fever, Across doses	897 15.1%	839 19.3%	235 7.9%	331 15.2%
Grade 3 Fever, Across doses	105 1.8%	26 0.6%	24 0.8%	11 0.5%
Related Fever, Across doses	547 9.2%	598 13.7%	110 3.7%	209 9.6%

43. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Assessed solicited local symptoms included pain, redness and swelling. Any = the incidence of a particular symptom, regardless of intensity grade. Grade 3 pain = cried when limb was moved, spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time Frame	During the 7-day (Days 0-6) post-booster vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	641	639	633	608	625	621
Any Pain	109 1.8%	45 1%	41 1.4%	59 2.7%	29 0.2%	25 NaN
Grade 3 Pain	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Any Redness	15 0.3%	13 0.3%	8 0.3%	9 0.4%	12 0.1%	9 NaN
Grade 3 Redness	3 0.1%	0 0%	0 0%	1 0%	0 0%	0 NaN
Any Swelling	42 0.7%	35 0.8%	30 1%	45 2.1%	28 0.2%	43 NaN
Grade 3 Swelling	9 0.2%	1 0%	0 0%	5 0.2%	0 0%	2 NaN

44. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame	During the 7-day (Days 0-6) post-booster vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	641	639	633	608	625	621
Any Drowsiness	55 0.9%	22 0.5%	21 0.7%	33 1.5%	19 0.1%	15 NaN
Grade 3 Drowsiness	1 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Related Drowsiness	34 0.6%	10 0.2%	13 0.4%	19 0.9%	6 0%	5 NaN
Any Irritability	63 1.1%	25 0.6%	18 0.6%	46 2.1%	23 0.1%	23 NaN
Grade 3 Irritability	1 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Related Irritability	40 0.7%	12 0.3%	8 0.3%	27 1.2%	10 0.1%	6 NaN
Any Loss of appetite	66 1.1%	27 0.6%	21 0.7%	45 2.1%	27 0.2%	18 NaN
Grade 3 Loss of appetite	1 0%	0 0%	0 0%	0 0%	0 0%	0 NaN
Related Loss of appetite	39 0.7%	14 0.3%	13 0.4%	26 1.2%	8 0.1%	6 NaN
Any Fever	233 3.9%	70 1.6%	45 1.5%	152 7%	52 0.3%	58 NaN
Grade 3 Fever	34 0.6%	6 0.1%	5 0.2%	9 0.4%	7 0%	10 NaN
Related Fever	151 2.5%	29 0.7%	16 0.5%	80 3.7%	15 0.1%	18 NaN

45. Secondary Outcome

Title	Number of Doses With Seizures by Diagnostic Certainty Level
Description	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.
Time Frame	During the 7-day (Days 0-6) post-booster vaccination period, at Month 20 + 7 Day (Days 0-6)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	2447	2472	2473	1825	1837	1827
Level 1	1	1	0	1	0	0
Level 2	5	2	1	3	0	1
Level 3	0	0	0	0	0	0
Level 4	1	0	0	0	0	0
Level 5	1	1	0	0	0	0

46. Secondary Outcome

Title	Number of Subjects Reporting Mucocutaneous Changes (All Levels)
Description	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).
Time Frame	During the 30-day (Days 0-29) post-booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	605	617	614
Count of Participants [Participants]	64 1.1%	47 1.1%	59 2%

47. Secondary Outcome

Title	Number of Subjects Reporting Any Meningitis and Encephalitis Serious Adverse Events (SAEs)
Description	Meningitis and encephalitis SAEs included: meningitis/encephalitis; meningitis/encephalitis viral; meningism; meningitis haemophilus; meningitis meningococcal; meningitis pneumococcal; meningitis tuberculous; encephalomyelitis.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	2976	2972	2974	2180	2178	2179
Count of Participants [Participants]	15 0.3%	12 0.3%	5 0.2%	7 0.3%	8 0.1%	7 NaN

48. Secondary Outcome

Title	Number of Subjects Reporting Any Meningitis and Encephalitis SAEs
Description	Meningitis and encephalitis SAEs included: meningitis/encephalitis; meningitis haemophilus; meningitis meningococcal; meningitis tuberculous; encephalomyelitis.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	2681	2719	2702	1966	1996	1976
Count of Participants [Participants]	4 0.1%	4 0.1%	0 0%	0 0%	2 0%	3 NaN

49. Secondary Outcome

Title	Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs)
Description	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.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	2976	2972	2974	2180	2178	2179
Count of Participants [Participants]	5 0.1%	1 0%	4 0.1%	3 0.1%	1 0%	2 NaN

50. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.
Time Frame	Within the 30-day (Days 0-29) post-primary vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	1479	1462	721	738
Count of Participants [Participants]	1273 21.4%	1161 26.6%	626 21%	600 27.5%

51. Secondary Outcome

Title	Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.
Time Frame	Within the 30-day (Days 0-29) post-primary vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	3997	4358	2003	2179
Count of Participants [Participants]	399 6.7%	578 13.3%	72 2.4%	231 10.6%

52. Secondary Outcome

Title	Number of Subjects With Any Unsolicited AEs
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs were calculated based on the first 200 subjects enrolled in each study center.
Time Frame	Within the 30-day (days 0-29) post-booster vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	641	639	633	608	625	621
Count of Participants [Participants]	232 3.9%	205 4.7%	215 7.2%	231 10.6%	239 1.5%	240 NaN

53. Secondary Outcome

Title	Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. 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).
Time Frame	Within the 30-day (Days 0-29) post-primary and post-booster vaccination period in HIV-infected children

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK257049 Group	GSK257049 -GSK257049 Group	GSK257049 - Menjugate Group	Comparator Group
Arm/Group Description	Pooled group between GSK257049 [5-17M] Group and GSK257049 [6-12W] Group.	Pooled group between GSK257049 -GSK257049 [5-17M] Group and GSK257049 -GSK257049 [6-12W] Group.	Pooled group between GSK257049 - Menjugate [5-17M] Group and GSK257049 - Menjugate [6-12W] Group.	Pooled Group between VeroRab Comparator [5-17M] Group and Menjugate Comparator [6-12W] Group.
Measure Participants	84	33	35	41
Any AE(s), post-primary vaccination	13 0.2%	0 0%	0 0%	3 0.1%
Any AE(s), post-booster vaccination	0 0%	2 0%	0 0%	0 0%

54. Secondary Outcome

Title	Number of Subjects With Unsolicited AEs Related to or Leading to Vaccination Withdrawal in the Low-weight (LW) and Very Low-weight (VLW) Category
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. 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). 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.
Time Frame	Within the 30-day (Days 0-29) post-primary vaccination period in HIV-infected children

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	695	221	364	126
Any AE(s), in LW	68 1.1%	38 0.9%	21 0.7%	17 0.8%
Any AE(s), in VLW	27 0.5%	24 0.6%	6 0.2%	10 0.5%

55. Secondary Outcome

Title	Number of Subjects With Unsolicited AEs Related to Vaccination in the Low-weight (LW) and Very Low-weight (VLW) Category
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. 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.
Time Frame	Within the 30-day (Days 0-29) post-booster vaccination period

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	273	297	293	230	208	195
Any AE(s) in LW	4 0.1%	1 0%	0 0%	2 0.1%	0 0%	0 NaN
Any AE(s) in VLW	5 0.1%	0 0%	1 0%	2 0.1%	0 0%	1 NaN

56. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	From Month 0 up to Month 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	5948	4358	2974	2179
Count of Participants [Participants]	1040 17.5%	782 17.9%	634 21.3%	419 19.2%

57. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	During the 30-day (Days 0-29) post-primary vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	5948	4358	2974	2179
Count of Participants [Participants]	312 5.2%	192 4.4%	181 6.1%	96 4.4%

58. Secondary Outcome

Title	Number of Subjects With Serious Adversee Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	From Month 0 up to Month 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	5948	4358	2974	2179
Count of Participants [Participants]	1108 18.6%	959 22%	676 22.7%	503 23.1%

59. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	2681	2719	2702	1966	1996	1976
Count of Participants [Participants]	276 4.6%	316 7.3%	287 9.7%	180 8.3%	193 1.2%	201 NaN

60. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	2976	2972	2974	2180	2178	2179
Count of Participants [Participants]	720 12.1%	752 17.3%	846 28.4%	580 26.6%	602 3.9%	619 NaN

61. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	Within the 30-day (Days 0-29) post-booster vaccination period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	2447	2472	2473	1825	1837	1827
Count of Participants [Participants]	34 0.6%	22 0.5%	27 0.9%	19 0.9%	19 0.1%	20 NaN

62. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	From Month 0 up to Booster (Month 20), from Month 0 up to study end and from Month 20 up to study end

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK257049 -GSK257049 Group	GSK257049 - Menjugate Group	Comparator Group
Arm/Group Description	Pooled group between GSK257049 -GSK257049 [5-17M] Group and GSK257049 -GSK257049 [6-12W] Group.	Pooled group between GSK257049 - Menjugate [5-17M] Group and GSK257049 - Menjugate [6-12W] Group.	Pooled Group between VeroRab Comparator [5-17M] Group and Menjugate Comparator [6-12W] Group.
Measure Participants	51	54	48
Any SAE(s), Month 0 - Month 20	43 0.7%	39 0.9%	36 1.2%
Any SAE(s), Month 0 - Study end	47 0.8%	46 1.1%	42 1.4%
Any SAE(s), Month 20 - Study end	19 0.3%	19 0.4%	16 0.5%

63. Secondary Outcome

Title	Number of Low-weight (LW) Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was > -3 and ≤ -2.
Time Frame	From Month 0 up to Month 20

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	695	221	364	126
Count of Participants [Participants]	174 2.9%	63 1.4%	89 3%	38 1.7%

64. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	277	304	297	232	211	195
Count of Participants [Participants]	32 0.5%	40 0.9%	38 1.3%	34 1.6%	21 0.1%	24 NaN

65. Secondary Outcome

Title	Number of Very Low-weight (VLW) Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Very low-weight subjects were defined as subjects whose weight for age z-score (WAZ) was ≤ -3.
Time Frame	From Month 0 up to Month 20

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK257049 [5-17M] Group	GSK257049 [6-12W] Group	VeroRab Comparator [5-17M] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	207	147	97	67
Count of Participants [Participants]	55 0.9%	48 1.1%	28 0.9%	17 0.8%

66. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	48	50	60	48	47	68
Count of Participants [Participants]	5 0.1%	8 0.2%	11 0.4%	6 0.3%	9 0.1%	15 NaN

67. Secondary Outcome

Title	Number of Subjects With Fatal Outcomes, by Gender
Description	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.
Time Frame	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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GSK257049 - GSK257049 [5-17M] Group	GSK257049 - Menjugate [5-17M] Group	VeroRab Comparator [5-17M] Group	GSK257049 -GSK257049 [6-12W] Group	GSK257049 - Menjugate [6-12W] Group	Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of the GSK257049 and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.	Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
Measure Participants	1509	1500	1503	1116	1118	1100
Overall Mortality (M0-M20), Females	27 0.5%	20 0.5%	14 0.5%	20 0.9%	24 0.2%	13 NaN
Overall Mortality (M0-SE), Females	35 0.6%	32 0.7%	17 0.6%	27 1.2%	29 0.2%	16 NaN
Overall Mortality (M0-M20), Males	19 0.3%	8 0.2%	19 0.6%	20 0.9%	20 0.1%	21 NaN
Overall Mortality (M0-SE), Males	26 0.4%	19 0.4%	29 1%	24 1.1%	26 0.2%	26 NaN
Severe Malaria SCD, All, Females	75 1.3%	107 2.5%	100 3.4%	57 2.6%	49 0.3%	75 NaN
Severe Malaria SCD, All, Males	87 1.5%	115 2.6%	134 4.5%	78 3.6%	80 0.5%	79 NaN
Severe Malaria SCD, Fatal, Females	4 0.1%	4 0.1%	2 0.1%	2 0.1%	0 0%	0 NaN
Severe Malaria SCD, Fatal, Males	3 0.1%	4 0.1%	2 0.1%	2 0.1%	2 0%	2 NaN
Cerebral Malaria SCD, All, Females	16 0.3%	14 0.3%	7 0.2%	1 0%	5 0%	7 NaN
Cerebral Malaria SCD, All, Males	10 0.2%	14 0.3%	9 0.3%	9 0.4%	7 0%	3 NaN
Cerebral Malaria SCD, Fatal, Females	3 0.1%	4 0.1%	2 0.1%	1 0%	0 0%	0 NaN
Cerebral Malaria SCD, Fatal, Males	2 0%	1 0%	0 0%	1 0%	1 0%	0 NaN
Meningitis, All, Females	5 0.1%	5 0.1%	1 0%	2 0.1%	2 0%	3 NaN
Meningitis, All, Males	6 0.1%	5 0.1%	2 0.1%	3 0.1%	5 0%	3 NaN
Meningitis, Fatal, Females	2 0%	3 0.1%	0 0%	0 0%	0 0%	1 NaN
Meningitis, Fatal, Males	2 0%	0 0%	1 0%	1 0%	1 0%	2 NaN
Fatal All-Cause Traumas, Females	3 0.1%	4 0.1%	1 0%	1 0%	1 0%	2 NaN
Fatal All-Cause Traumas, Males	4 0.1%	1 0%	3 0.1%	1 0%	2 0%	0 NaN
Fatal Malaria, Females	9 0.2%	8 0.2%	4 0.1%	5 0.2%	4 0%	3 NaN
Fatal Malaria, Males	4 0.1%	9 0.2%	8 0.3%	3 0.1%	8 0.1%	3 NaN

Adverse Events

Time Frame	Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination periods; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination periods; SAEs: from Day 0 up to study end (median follow-up of 48 months for 5-17M subjects and of 38 months for 6-12W subjects).
Arm/Group Title	GSK257049 [5-17M] Group		GSK257049 [6-12W] Group		VeroRab Comparator [5-17M] Group		Menjugate Comparator [6-12W] Group
Arm/Group Description	Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.		Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin™ vaccines or a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 20. All vaccines have been administered intramuscularly in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.		Male or female children between and including 5 to 17 months of age [5-17M], who received a 3-dose primary vaccination course of the VeroRab® vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid.		Male or female children between and including 6 to 12 weeks of age [6-12W], who received a 3-dose primary vaccination course of Menjugate® vaccine co-administered with Polio Sabin™ and Tritanrix HepB™/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate® and Polio Sabin™ vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate® vaccine); anterolateral right thigh (Tritanrix HepB™/Hib vaccine), except for the Polio Sabin™ vaccine, which has been given orally.
All Cause Mortality
	GSK257049 [5-17M] Group		GSK257049 [6-12W] Group		VeroRab Comparator [5-17M] Group		Menjugate Comparator [6-12W] Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	112/5948 (1.9%)		46/4358 (1.1%)		106/2974 (3.6%)		42/2179 (1.9%)
Serious Adverse Events
	GSK257049 [5-17M] Group		GSK257049 [6-12W] Group		VeroRab Comparator [5-17M] Group		Menjugate Comparator [6-12W] Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1475/5948 (24.8%)		1186/4358 (27.2%)		848/2974 (28.5%)		622/2179 (28.5%)
Blood and lymphatic system disorders
Anaemia	277/5948 (4.7%)	329	198/4358 (4.5%)	258	198/2974 (6.7%)	246	116/2179 (5.3%)	138
Disseminated intravascular coagulation	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Haemolysis	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Haemolytic anaemia	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	1/2179 (0%)	1
Hypochromic anaemia	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Intravascular haemolysis	1/5948 (0%)	1	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Leukaemoid reaction	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Lymphadenitis	7/5948 (0.1%)	7	1/4358 (0%)	1	1/2974 (0%)	1	2/2179 (0.1%)	2
Neutropenia	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Pancytopenia	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Thrombocytopenia	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Cardiac disorders
Cardiac arrest	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Cardiac failure	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Cardiomyopathy	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Pericardial effusion	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Congenital, familial and genetic disorders
Atrial septal defect	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Cerebral palsy	1/5948 (0%)	1	2/4358 (0%)	2	0/2974 (0%)	0	0/2179 (0%)	0
Choledochal cyst	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Congenital megacolon	0/5948 (0%)	0	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Cryptorchism	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Fallot's tetralogy	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Glucose-6-phosphate dehydrogenase deficiency	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Hydrocele	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Phimosis	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	1/2179 (0%)	1
Sickle cell anaemia	5/5948 (0.1%)	5	4/4358 (0.1%)	4	1/2974 (0%)	1	5/2179 (0.2%)	5
Sickle cell anaemia with crisis	8/5948 (0.1%)	15	5/4358 (0.1%)	10	6/2974 (0.2%)	8	5/2179 (0.2%)	10
Trisomy 21	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Urethral valves	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Ventricular septal defect	0/5948 (0%)	0	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Ear and labyrinth disorders
Deafness	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Hearing impaired	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Eye disorders
Periorbital oedema	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Gastrointestinal disorders
Abdominal pain	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Aphthous stomatitis	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Colitis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Constipation	0/5948 (0%)	0	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Enteritis	28/5948 (0.5%)	28	17/4358 (0.4%)	17	15/2974 (0.5%)	15	18/2179 (0.8%)	18
Food poisoning	1/5948 (0%)	1	0/4358 (0%)	0	2/2974 (0.1%)	2	1/2179 (0%)	1
Gastritis	2/5948 (0%)	2	3/4358 (0.1%)	3	2/2974 (0.1%)	2	4/2179 (0.2%)	4
Gastrointestinal haemorrhage	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Gastrointestinal motility disorder	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Gastrooesophageal reflux disease	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Haematemesis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Ileus paralytic	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Inguinal hernia	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	3/2179 (0.1%)	3
Inguinal hernia, obstructive	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Intestinal obstruction	1/5948 (0%)	1	2/4358 (0%)	3	0/2974 (0%)	0	0/2179 (0%)	0
Intestinal perforation	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Intussusception	0/5948 (0%)	0	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Mouth ulceration	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Rectal polyp	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Rectal prolapse	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Stomatitis	1/5948 (0%)	1	2/4358 (0%)	2	1/2974 (0%)	1	0/2179 (0%)	0
Stress ulcer	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Umbilical hernia	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Umbilical hernia, obstructive	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Upper gastrointestinal haemorrhage	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Vomiting	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	0/2179 (0%)	0
General disorders
Death	4/5948 (0.1%)	4	3/4358 (0.1%)	3	0/2974 (0%)	0	3/2179 (0.1%)	3
Drowning	5/5948 (0.1%)	5	1/4358 (0%)	1	3/2974 (0.1%)	3	1/2179 (0%)	1
Generalised oedema	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Hernia	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Hypothermia	2/5948 (0%)	2	2/4358 (0%)	2	0/2974 (0%)	0	1/2179 (0%)	1
Injection site reaction	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Pyrexia	28/5948 (0.5%)	28	27/4358 (0.6%)	27	16/2974 (0.5%)	16	18/2179 (0.8%)	18
Hepatobiliary disorders
Cholecystitis	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Hepatitis	2/5948 (0%)	2	2/4358 (0%)	2	1/2974 (0%)	1	0/2179 (0%)	0
Hepatitis acute	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Hepatitis toxic	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Immune system disorders
Allergy to arthropod sting	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	2/2179 (0.1%)	2
Anaphylactic reaction	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	1/2179 (0%)	1
Drug hypersensitivity	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Hypersensitivity	3/5948 (0.1%)	3	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Immune reconstitution inflammatory syndrome	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Infections and infestations
Abscess	14/5948 (0.2%)	14	12/4358 (0.3%)	12	5/2974 (0.2%)	5	5/2179 (0.2%)	5
Abscess jaw	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Abscess limb	1/5948 (0%)	1	1/4358 (0%)	1	3/2974 (0.1%)	3	1/2179 (0%)	1
Abscess neck	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Acarodermatitis	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Aids dementia complex	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Amoebiasis	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Arthritis bacterial	9/5948 (0.2%)	9	6/4358 (0.1%)	6	1/2974 (0%)	1	1/2179 (0%)	1
Ascariasis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Atypical pneumonia	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	0/2179 (0%)	0
Bacteraemia	2/5948 (0%)	2	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Bacterial infection	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	2/2179 (0.1%)	2
Bone tuberculosis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Brain abscess	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Breast abscess	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Bronchiolitis	38/5948 (0.6%)	42	32/4358 (0.7%)	33	18/2974 (0.6%)	24	24/2179 (1.1%)	26
Bronchitis	28/5948 (0.5%)	31	17/4358 (0.4%)	18	21/2974 (0.7%)	22	3/2179 (0.1%)	3
Bronchopneumonia	68/5948 (1.1%)	76	54/4358 (1.2%)	60	40/2974 (1.3%)	42	34/2179 (1.6%)	36
Bullous impetigo	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Burkholderia cepacia complex sepsis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Burn infection	3/5948 (0.1%)	3	1/4358 (0%)	1	0/2974 (0%)	0	1/2179 (0%)	1
Candida infection	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Cellulitis	15/5948 (0.3%)	15	10/4358 (0.2%)	10	6/2974 (0.2%)	6	6/2179 (0.3%)	6
Cellulitis of male external genital organ	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Cellulitis orbital	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Cellulitis pharyngeal	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Central nervous system viral infection	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Cerebral malaria	8/5948 (0.1%)	8	2/4358 (0%)	3	0/2974 (0%)	0	2/2179 (0.1%)	2
Cholera	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Conjunctivitis	6/5948 (0.1%)	6	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Conjunctivitis bacterial	1/5948 (0%)	1	2/4358 (0%)	2	1/2974 (0%)	1	0/2179 (0%)	0
Croup infectious	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	2	0/2179 (0%)	0
Dermatitis infected	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Disseminated tuberculosis	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Dysentery	24/5948 (0.4%)	24	10/4358 (0.2%)	10	9/2974 (0.3%)	9	7/2179 (0.3%)	7
Eczema infected	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Empyema	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Encephalitis	5/5948 (0.1%)	5	1/4358 (0%)	1	2/2974 (0.1%)	2	1/2179 (0%)	1
Encephalitis viral	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Encephalomyelitis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Enterococcal sepsis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Erysipelas	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Escherichia sepsis	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	2/2179 (0.1%)	2
Escherichia urinary tract infection	1/5948 (0%)	1	3/4358 (0.1%)	3	2/2974 (0.1%)	2	2/2179 (0.1%)	2
Exanthema subitum	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Febrile infection	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Furuncle	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Gastroenteritis	302/5948 (5.1%)	335	333/4358 (7.6%)	379	177/2974 (6%)	192	171/2179 (7.8%)	192
Gastroenteritis escherichia coli	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Gastroenteritis salmonella	5/5948 (0.1%)	5	7/4358 (0.2%)	7	0/2974 (0%)	0	4/2179 (0.2%)	4
Gastroenteritis shigella	1/5948 (0%)	1	1/4358 (0%)	1	1/2974 (0%)	1	1/2179 (0%)	1
Gastroenteritis viral	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Gastrointestinal candidiasis	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Giardiasis	0/5948 (0%)	0	1/4358 (0%)	1	1/2974 (0%)	1	1/2179 (0%)	1
Gingivitis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Groin abscess	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Haemophilus sepsis	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Helminthic infection	10/5948 (0.2%)	12	3/4358 (0.1%)	3	6/2974 (0.2%)	6	1/2179 (0%)	1
Hepatitis a	4/5948 (0.1%)	4	0/4358 (0%)	0	1/2974 (0%)	1	1/2179 (0%)	1
Hepatitis b	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Hepatitis infectious	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Hiv associated nephropathy	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Hiv infection	41/5948 (0.7%)	41	36/4358 (0.8%)	36	18/2974 (0.6%)	18	12/2179 (0.6%)	12
Hiv infection who clinical stage ii	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Hiv infection who clinical stage iii	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	0/2179 (0%)	0
Hiv infection who clinical stage iv	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Impetigo	3/5948 (0.1%)	3	4/4358 (0.1%)	4	3/2974 (0.1%)	3	1/2179 (0%)	1
Infected skin ulcer	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Infection	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Injection site abscess	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Injection site cellulitis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Klebsiella sepsis	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Laryngitis	1/5948 (0%)	1	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Listeria sepsis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Liver abscess	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Lobar pneumonia	11/5948 (0.2%)	11	17/4358 (0.4%)	18	7/2974 (0.2%)	8	7/2179 (0.3%)	8
Lower respiratory tract infection	5/5948 (0.1%)	5	4/4358 (0.1%)	4	6/2974 (0.2%)	6	2/2179 (0.1%)	2
Ludwig angina	2/5948 (0%)	2	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Lymph node abscess	2/5948 (0%)	2	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Lymph node tuberculosis	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Lymphadenitis bacterial	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Malaria	639/5948 (10.7%)	850	392/4358 (9%)	525	423/2974 (14.2%)	533	236/2179 (10.8%)	303
Mastoiditis	2/5948 (0%)	2	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Measles	9/5948 (0.2%)	9	24/4358 (0.6%)	24	5/2974 (0.2%)	5	8/2179 (0.4%)	8
Meningitis	10/5948 (0.2%)	10	5/4358 (0.1%)	5	1/2974 (0%)	1	3/2179 (0.1%)	3
Meningitis haemophilus	3/5948 (0.1%)	3	1/4358 (0%)	1	0/2974 (0%)	0	1/2179 (0%)	1
Meningitis meningococcal	5/5948 (0.1%)	5	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Meningitis pneumococcal	1/5948 (0%)	1	3/4358 (0.1%)	3	0/2974 (0%)	0	2/2179 (0.1%)	2
Meningitis salmonella	0/5948 (0%)	0	4/4358 (0.1%)	4	0/2974 (0%)	0	0/2179 (0%)	0
Meningitis tuberculous	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Meningitis viral	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Moraxella infection	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Mumps	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Mycobacterium ulcerans infection	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Nasopharyngitis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Oral candidiasis	10/5948 (0.2%)	10	3/4358 (0.1%)	3	4/2974 (0.1%)	5	1/2179 (0%)	1
Oropharyngeal candidiasis	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Osteomyelitis	5/5948 (0.1%)	5	2/4358 (0%)	2	3/2974 (0.1%)	3	2/2179 (0.1%)	2
Otitis externa	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Otitis media	29/5948 (0.5%)	29	22/4358 (0.5%)	22	22/2974 (0.7%)	22	7/2179 (0.3%)	7
Otitis media acute	4/5948 (0.1%)	4	3/4358 (0.1%)	3	2/2974 (0.1%)	2	1/2179 (0%)	1
Otitis media chronic	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Parotitis	2/5948 (0%)	2	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Perineal abscess	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Periorbital cellulitis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Peritonitis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Pharyngitis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Plasmodium ovale infection	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Pneumococcal bacteraemia	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	0/2179 (0%)	0
Pneumococcal sepsis	9/5948 (0.2%)	9	9/4358 (0.2%)	10	3/2974 (0.1%)	3	3/2179 (0.1%)	3
Pneumocystis jirovecii pneumonia	2/5948 (0%)	2	5/4358 (0.1%)	5	1/2974 (0%)	1	0/2179 (0%)	0
Pneumonia	417/5948 (7%)	532	424/4358 (9.7%)	547	223/2974 (7.5%)	287	202/2179 (9.3%)	286
Pneumonia pneumococcal	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	0/2179 (0%)	0
Pneumonia streptococcal	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Pneumonia viral	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Postoperative wound infection	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Pseudomonal sepsis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Pulmonary tuberculosis	8/5948 (0.1%)	9	12/4358 (0.3%)	12	4/2974 (0.1%)	4	2/2179 (0.1%)	2
Pyelonephritis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Pyoderma	2/5948 (0%)	2	0/4358 (0%)	0	3/2974 (0.1%)	3	0/2179 (0%)	0
Pyomyositis	2/5948 (0%)	2	2/4358 (0%)	2	3/2974 (0.1%)	3	0/2179 (0%)	0
Rabies	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Respiratory tract infection	4/5948 (0.1%)	4	1/4358 (0%)	1	2/2974 (0.1%)	2	0/2179 (0%)	0
Rubella	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Salmonella bacteraemia	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Salmonella sepsis	70/5948 (1.2%)	73	60/4358 (1.4%)	63	42/2974 (1.4%)	42	37/2179 (1.7%)	40
Salmonellosis	4/5948 (0.1%)	4	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Schistosomiasis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Sepsis	60/5948 (1%)	61	38/4358 (0.9%)	38	43/2974 (1.4%)	46	13/2179 (0.6%)	15
Septic shock	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Shigella infection	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Skin bacterial infection	2/5948 (0%)	2	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Skin infection	3/5948 (0.1%)	3	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Staphylococcal sepsis	9/5948 (0.2%)	10	10/4358 (0.2%)	10	1/2974 (0%)	1	2/2179 (0.1%)	2
Staphylococcal skin infection	3/5948 (0.1%)	3	1/4358 (0%)	1	2/2974 (0.1%)	2	1/2179 (0%)	1
Streptococcal infection	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Streptococcal sepsis	2/5948 (0%)	2	2/4358 (0%)	2	2/2974 (0.1%)	2	2/2179 (0.1%)	2
Subcutaneous abscess	9/5948 (0.2%)	9	7/4358 (0.2%)	7	2/2974 (0.1%)	2	3/2179 (0.1%)	3
Superinfection	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Taeniasis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Tinea capitis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Tonsillitis	2/5948 (0%)	2	3/4358 (0.1%)	3	3/2974 (0.1%)	3	0/2179 (0%)	0
Toxic shock syndrome	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Tracheobronchitis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Trichiniasis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Tuberculosis	9/5948 (0.2%)	9	6/4358 (0.1%)	6	6/2974 (0.2%)	6	3/2179 (0.1%)	3
Typhoid fever	2/5948 (0%)	3	1/4358 (0%)	1	3/2974 (0.1%)	3	0/2179 (0%)	0
Upper respiratory tract infection	68/5948 (1.1%)	74	50/4358 (1.1%)	52	43/2974 (1.4%)	45	24/2179 (1.1%)	24
Urinary tract infection	45/5948 (0.8%)	47	26/4358 (0.6%)	28	28/2974 (0.9%)	29	22/2179 (1%)	23
Urinary tract infection bacterial	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Urinary tract infection pseudomonal	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Urosepsis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Vaginal infection	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Varicella	1/5948 (0%)	1	3/4358 (0.1%)	3	1/2974 (0%)	1	1/2179 (0%)	1
Viral infection	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Wound infection	2/5948 (0%)	2	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Wound sepsis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Injury, poisoning and procedural complications
Accidental exposure to product	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Accidental poisoning	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Animal bite	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Arthropod sting	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Bronchitis chemical	4/5948 (0.1%)	4	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Burns first degree	4/5948 (0.1%)	4	2/4358 (0%)	2	1/2974 (0%)	1	1/2179 (0%)	1
Burns second degree	6/5948 (0.1%)	6	5/4358 (0.1%)	5	2/2974 (0.1%)	2	3/2179 (0.1%)	3
Chemical injury	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Chemical poisoning	2/5948 (0%)	2	0/4358 (0%)	0	7/2974 (0.2%)	7	0/2179 (0%)	0
Clavicle fracture	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Crush injury	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Disinfectant poisoning	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Dislocation of vertebra	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Exposure to toxic agent	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Eye contusion	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Eye injury	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Femur fracture	3/5948 (0.1%)	3	4/4358 (0.1%)	4	1/2974 (0%)	1	2/2179 (0.1%)	2
Foreign body	5/5948 (0.1%)	5	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Foreign body aspiration	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Fractured skull depressed	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Greenstick fracture	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Head injury	2/5948 (0%)	2	4/4358 (0.1%)	4	1/2974 (0%)	1	0/2179 (0%)	0
Herbal toxicity	5/5948 (0.1%)	5	2/4358 (0%)	2	2/2974 (0.1%)	2	3/2179 (0.1%)	3
Human bite	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Humerus fracture	2/5948 (0%)	2	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Joint injury	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Laceration	1/5948 (0%)	1	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Limb injury	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Limb traumatic amputation	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Penis injury	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Petroleum distillate poisoning	4/5948 (0.1%)	4	1/4358 (0%)	1	4/2974 (0.1%)	4	1/2179 (0%)	1
Pneumonitis chemical	5/5948 (0.1%)	5	4/4358 (0.1%)	4	4/2974 (0.1%)	4	0/2179 (0%)	0
Poisoning	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Pulmonary contusion	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Road traffic accident	1/5948 (0%)	1	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Sciatic nerve injury	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Skin injury	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Snake bite	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Soft tissue injury	2/5948 (0%)	2	2/4358 (0%)	2	0/2974 (0%)	0	3/2179 (0.1%)	3
Thermal burn	25/5948 (0.4%)	26	24/4358 (0.6%)	24	15/2974 (0.5%)	15	11/2179 (0.5%)	11
Tibia fracture	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Vaccination failure	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	2/2179 (0.1%)	2
Wound	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Wrist fracture	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Metabolism and nutrition disorders
Dehydration	2/5948 (0%)	2	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Failure to thrive	1/5948 (0%)	1	1/4358 (0%)	1	2/2974 (0.1%)	2	1/2179 (0%)	1
Hyperkalaemia	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Hypoglycaemia	20/5948 (0.3%)	21	6/4358 (0.1%)	6	18/2974 (0.6%)	20	3/2179 (0.1%)	3
Hypokalaemia	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Hypoproteinaemia	2/5948 (0%)	2	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Kwashiorkor	15/5948 (0.3%)	18	16/4358 (0.4%)	17	17/2974 (0.6%)	17	4/2179 (0.2%)	4
Malnutrition	54/5948 (0.9%)	58	50/4358 (1.1%)	58	21/2974 (0.7%)	25	19/2179 (0.9%)	21
Marasmus	14/5948 (0.2%)	14	11/4358 (0.3%)	11	4/2974 (0.1%)	4	7/2179 (0.3%)	8
Metabolic acidosis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Underweight	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Musculoskeletal and connective tissue disorders
Arthritis	2/5948 (0%)	2	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Compartment syndrome	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Dactylitis	0/5948 (0%)	0	2/4358 (0%)	2	0/2974 (0%)	0	1/2179 (0%)	1
Joint effusion	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Myositis	3/5948 (0.1%)	3	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Osteoarthritis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Rickets	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Torticollis	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Brain neoplasm	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Inflammatory pseudotumour	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Langerhans' cell histiocytosis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Nervous system disorders
Arachnoid cyst	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Cerebellar ataxia	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Cerebral atrophy	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Convulsion	102/5948 (1.7%)	122	78/4358 (1.8%)	98	58/2974 (2%)	64	32/2179 (1.5%)	45
Depressed level of consciousness	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Encephalomalacia	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Encephalopathy	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Epilepsy	13/5948 (0.2%)	14	3/4358 (0.1%)	5	2/2974 (0.1%)	2	0/2179 (0%)	0
Febrile convulsion	344/5948 (5.8%)	466	191/4358 (4.4%)	248	166/2974 (5.6%)	221	103/2179 (4.7%)	127
Haemorrhage intracranial	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Hemiparesis	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Hemiplegia	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	2	0/2179 (0%)	0
Hydrocephalus	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Loss of consciousness	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Meningism	0/5948 (0%)	0	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Mental retardation	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Metabolic encephalopathy	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Monoparesis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Myoclonus	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Paraparesis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	1/2179 (0%)	1
Speech disorder developmental	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Uraemic encephalopathy	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Psychiatric disorders
Neurodevelopmental disorder	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Renal and urinary disorders
Glomerulonephritis	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Glomerulonephritis acute	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Hydronephrosis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Nephritis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Nephrotic syndrome	1/5948 (0%)	2	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Renal failure acute	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Renal tubular necrosis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Urinary retention	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Reproductive system and breast disorders
Acquired phimosis	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	1/2179 (0%)	1
Respiratory, thoracic and mediastinal disorders
Apnoeic attack	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Asphyxia	1/5948 (0%)	1	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Aspiration	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Asthma	15/5948 (0.3%)	21	9/4358 (0.2%)	9	8/2974 (0.3%)	19	7/2179 (0.3%)	7
Bronchial hyperreactivity	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	1/2179 (0%)	1
Bronchospasm	2/5948 (0%)	2	8/4358 (0.2%)	8	3/2974 (0.1%)	3	5/2179 (0.2%)	7
Cough	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Epistaxis	0/5948 (0%)	0	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Interstitial lung disease	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Obstructive airways disorder	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Pleural effusion	1/5948 (0%)	1	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Pneumonia aspiration	8/5948 (0.1%)	8	4/4358 (0.1%)	4	6/2974 (0.2%)	6	4/2179 (0.2%)	4
Pneumonitis	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	1/2179 (0%)	1
Pulmonary oedema	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Respiratory acidosis	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Respiratory arrest	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Respiratory disorder	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis	2/5948 (0%)	2	0/4358 (0%)	0	2/2974 (0.1%)	2	0/2179 (0%)	0
Dermatitis allergic	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Dermatitis exfoliative	0/5948 (0%)	0	1/4358 (0%)	1	0/2974 (0%)	0	0/2179 (0%)	0
Drug eruption	0/5948 (0%)	0	0/4358 (0%)	0	0/2974 (0%)	0	1/2179 (0%)	1
Erythema multiforme	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Rash	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Rash maculo-papular	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Rash papular	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Skin lesion	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Stevens-johnson syndrome	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Urticaria	2/5948 (0%)	2	2/4358 (0%)	2	1/2974 (0%)	1	0/2179 (0%)	0
Vitiligo	0/5948 (0%)	0	0/4358 (0%)	0	1/2974 (0%)	1	0/2179 (0%)	0
Social circumstances
Child abuse	1/5948 (0%)	1	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Sexual abuse	2/5948 (0%)	3	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Vascular disorders
Haematoma	2/5948 (0%)	2	0/4358 (0%)	0	0/2974 (0%)	0	0/2179 (0%)	0
Hypovolaemic shock	0/5948 (0%)	0	1/4358 (0%)	1	1/2974 (0%)	1	0/2179 (0%)	0
Shock	3/5948 (0.1%)	3	3/4358 (0.1%)	3	5/2974 (0.2%)	5	4/2179 (0.2%)	4
Other (Not Including Serious) Adverse Events
	GSK257049 [5-17M] Group		GSK257049 [6-12W] Group		VeroRab Comparator [5-17M] Group		Menjugate Comparator [6-12W] Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1410/1479 (95.3%)		1360/1462 (93%)		664/721 (92.1%)		691/738 (93.6%)
Gastrointestinal disorders
Diarrhoea	196/1479 (13.3%)	226	0/1462 (0%)	0	92/721 (12.8%)	107	0/738 (0%)	0
Enteritis	136/1479 (9.2%)	148	149/1462 (10.2%)	195	65/721 (9%)	74	80/738 (10.8%)	97
General disorders
Pain	493/1479 (33.3%)	688	729/1462 (49.9%)	1251	132/721 (18.3%)	165	348/738 (47.2%)	571
Pyrexia	1028/1479 (69.5%)	1971	966/1462 (66.1%)	1852	306/721 (42.4%)	416	408/738 (55.3%)	660
Swelling	352/1479 (23.8%)	491	456/1462 (31.2%)	713	138/721 (19.1%)	192	272/738 (36.9%)	407
Infections and infestations
Bronchitis	83/1479 (5.6%)	92	69/1462 (4.7%)	80	37/721 (5.1%)	41	33/738 (4.5%)	36
Conjunctivitis	126/1479 (8.5%)	135	139/1462 (9.5%)	147	74/721 (10.3%)	77	81/738 (11%)	87
Gastroenteritis	368/1479 (24.9%)	435	257/1462 (17.6%)	339	159/721 (22.1%)	188	150/738 (20.3%)	207
Malaria	305/1479 (20.6%)	422	199/1462 (13.6%)	249	207/721 (28.7%)	289	108/738 (14.6%)	141
Otitis media	0/1479 (0%)	0	73/1462 (5%)	82	0/721 (0%)	0	41/738 (5.6%)	42
Pneumonia	175/1479 (11.8%)	200	87/1462 (6%)	94	72/721 (10%)	84	33/738 (4.5%)	36
Rhinitis	123/1479 (8.3%)	139	166/1462 (11.4%)	183	52/721 (7.2%)	59	94/738 (12.7%)	109
Upper respiratory tract infection	683/1479 (46.2%)	1006	655/1462 (44.8%)	1014	343/721 (47.6%)	493	344/738 (46.6%)	503
Viral upper respiratory tract infection	111/1479 (7.5%)	126	90/1462 (6.2%)	111	60/721 (8.3%)	69	49/738 (6.6%)	55
Metabolism and nutrition disorders
Decreased appetite	444/1479 (30%)	609	281/1462 (19.2%)	412	151/721 (20.9%)	190	114/738 (15.4%)	158
Nervous system disorders
Somnolence	272/1479 (18.4%)	364	302/1462 (20.7%)	475	87/721 (12.1%)	115	131/738 (17.8%)	179
Psychiatric disorders
Irritability	412/1479 (27.9%)	583	589/1462 (40.3%)	1017	106/721 (14.7%)	131	255/738 (34.6%)	411
Respiratory, thoracic and mediastinal disorders
Cough	119/1479 (8%)	126	0/1462 (0%)	0	47/721 (6.5%)	54	0/738 (0%)	0
Skin and subcutaneous tissue disorders
Erythema	147/1479 (9.9%)	162	307/1462 (21%)	436	57/721 (7.9%)	66	172/738 (23.3%)	254

Limitations/Caveats

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Principal Investigators are NOT employed by the organization sponsoring the study.

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.