Trial Outcomes & Findings for An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa (NCT NCT02207816)

Results Overview

Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3084 participants

Primary outcome timeframe

From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Results posted on

2019-11-25

Participant Flow

The randomization that was performed in the primary study NCT00866619 was kept for this extension, in which subjects from 3 sites were enrolled. Subjects remained in the same groups as the ones of the primary study.

Participant milestones

Participant milestones
Measure	GSK257049 Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.	GSK257049 Comparator Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.	VeroRab/Menjugate Comparator Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
Overall Study STARTED	1046	1010	1028
Overall Study COMPLETED	995	924	961
Overall Study NOT COMPLETED	51	86	67

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK257049 Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.	GSK257049 Comparator Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.	VeroRab/Menjugate Comparator Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
Overall Study Serious Adverse Event	0	5	2
Overall Study Eligibility Criteria Not Fulfilled	2	1	2
Overall Study Withdrawal by Subject	4	9	7
Overall Study Migrated/Moved From Study Area	41	60	51
Overall Study Lost to Follow-up	3	9	1
Overall Study Other	1	2	4

Baseline Characteristics

An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK257049 Group n=1046 Participants Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.	GSK257049 Comparator Group n=1010 Participants Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.	VeroRab/Menjugate Comparator Group n=1028 Participants Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.	Total n=3084 Participants Total of all reporting groups
Age, Continuous	5.25 Years STANDARD_DEVIATION 0.99 • n=5 Participants	5.23 Years STANDARD_DEVIATION 0.99 • n=7 Participants	5.26 Years STANDARD_DEVIATION 0.97 • n=5 Participants	5.25 Years STANDARD_DEVIATION 0.98 • n=4 Participants
Sex: Female, Male Female	517 Participants n=5 Participants	480 Participants n=7 Participants	515 Participants n=5 Participants	1512 Participants n=4 Participants
Sex: Female, Male Male	529 Participants n=5 Participants	530 Participants n=7 Participants	513 Participants n=5 Participants	1572 Participants n=4 Participants
Race/Ethnicity, Customized African Heritage/African American	1046 Participants n=5 Participants	1010 Participants n=7 Participants	1028 Participants n=5 Participants	3084 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding study vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=459 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=456 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=442 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Incidence of Severe Malaria Meeting Case Definition 1	0.001 events per person-year	0.002 events per person-year	0.002 events per person-year	0.004 events per person-year	0.003 events per person-year	0.005 events per person-year

PRIMARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=459 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=456 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=442 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Incidence of Severe Malaria Meeting Case Definition 2.	0.004 events per person-year	0.007 events per person-year	0.009 events per person-year	0.007 events per person-year	0.007 events per person-year	0.011 events per person-year

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=459 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=456 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=442 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Incidence of Clinical Malaria Meeting Case Definition	1.079 events per person-year	1.108 events per person-year	1.016 events per person-year	1.632 events per person-year	1.563 events per person-year	1.686 events per person-year

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=459 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=456 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=442 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.	7 Participants	11 Participants	14 Participants	10 Participants	10 Participants	13 Participants

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=459 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=456 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=442 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.	7 Participants	8 Participants	13 Participants	10 Participants	9 Participants	14 Participants

SECONDARY outcome

Timeframe: At Years 1, 2 and 3

Population: The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment

Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (\>) 0 parasites/µL, identified at an annual visit.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=565 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=525 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=436 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=435 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=420 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Prevalent Parasitemia Prevalent parasitemia, Year 1	52 Participants	46 Participants	89 Participants	48 Participants	65 Participants	61 Participants
Number of Subjects With Prevalent Parasitemia Prevalent parasitemia, Year 2	132 Participants	127 Participants	156 Participants	116 Participants	133 Participants	123 Participants
Number of Subjects With Prevalent Parasitemia Prevalent parasitemia, Year 3	135 Participants	148 Participants	158 Participants	106 Participants	105 Participants	99 Participants

SECONDARY outcome

Timeframe: At Years 1, 2 and 3

Population: The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.

Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (\<) 5.0 grams per deciliter (g/dL), identified at an annual visit.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=565 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=528 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=562 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=437 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=436 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=421 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) Prevalent severe anemia, Year 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) Prevalent severe anemia, Year 2	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) Prevalent severe anemia, Year 3	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Years 1, 2 and 3

Population: The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.

Prevalent moderate anemia (PMA) was defined as a documented hemoglobin \< 8.0 g/dL, identified at an annual visit.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=565 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=528 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=562 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=437 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=436 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=421 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) Prevalent moderate anemia, Year 1	7 Participants	9 Participants	2 Participants	16 Participants	6 Participants	11 Participants
Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) Prevalent moderate anemia, Year 2	7 Participants	10 Participants	11 Participants	18 Participants	15 Participants	8 Participants
Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) Prevalent moderate anemia, Year 3	4 Participants	4 Participants	7 Participants	10 Participants	6 Participants	8 Participants

SECONDARY outcome

Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.

Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=844 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=829 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=839 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=637 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=635 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=633 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Incidence of Severe Malaria Meeting Case Definition 1.	0.009 events per person-year	0.016 events per person-year	0.015 events per person-year	0.014 events per person-year	0.013 events per person-year	0.02 events per person-year

SECONDARY outcome

Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.

Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=844 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=829 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=839 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=637 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=635 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=633 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Incidence of Severe Malaria Meeting Case Definition 2.	0.015 events per person-year	0.021 events per person-year	0.023 events per person-year	0.019 events per person-year	0.019 events per person-year	0.028 events per person-year

SECONDARY outcome

Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.

Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=844 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=829 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=839 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=637 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=635 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=633 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Incidence of Clinical Malaria Meeting Case Definition	1.277 events per subject-year	1.348 events per subject-year	1.555 events per subject-year	1.662 events per subject-year	1.723 events per subject-year	1.921 events per subject-year

SECONDARY outcome

Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.

Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=844 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=829 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=839 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=637 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=635 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=633 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.	61 Participants	82 Participants	94 Participants	52 Participants	60 Participants	73 Participants

SECONDARY outcome

Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.

Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=844 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=829 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=839 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=637 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=635 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=633 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.	60 Participants	79 Participants	93 Participants	54 Participants	60 Participants	75 Participants

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=459 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=456 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=442 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=459 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=456 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=442 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Fatal Malaria Meeting Case Definition 1.	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=561 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=459 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=456 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=442 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Fatal Malaria Meeting Case Definition 2.	1 Participants	2 Participants	2 Participants	3 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.

Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=844 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=829 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=839 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=637 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=635 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=633 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Cerebral Malaria	4 Participants	10 Participants	2 Participants	3 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.

Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=844 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=829 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=839 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=637 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=635 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=633 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Fatal Malaria Meeting Case Definition 1.	2 Participants	4 Participants	1 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.

Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=844 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=829 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=839 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=637 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=635 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=633 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Fatal Malaria Meeting Case Definition 2.	5 Participants	7 Participants	4 Participants	4 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as 'malaria', 'Plasmodium falciparum infection' or 'cerebral malaria". A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=560 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=457 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=455 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=440 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) Fatal SAE(s)	2 Participants	7 Participants	5 Participants	3 Participants	3 Participants	2 Participants
Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) Any SAE(s)	20 Participants	25 Participants	27 Participants	19 Participants	18 Participants	25 Participants
Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) Related SAE(s)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) Malaria SAE(s)	19 Participants	20 Participants	24 Participants	17 Participants	16 Participants	24 Participants

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

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. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=560 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=457 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=455 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=440 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=594 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=560 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=593 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=457 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=455 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=440 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Number of Subjects With Meningitis SAEs Meningitis meningococcal	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Meningitis SAEs Meningitis	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Meningitis SAEs Meningitis bacterial	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)

Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.

Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.

Outcome measures

Outcome measures
Measure	GSK257049 [5-17M] Group n=154 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of the same GSK257049 vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 Comparator [5-17M] Group n=152 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	VeroRab Comparator [5-17M] Group n=160 Participants Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20, in study NCT00866619 (Malaria-055). Both vaccines were administered intramuscularly into the left deltoid. No vaccination was administered during this study.	GSK257049 [6-12W] Group n=141 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.	GSK257049 Comparator [6-12W] Group n=153 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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), except for the Polio Sabin vaccine, which was given orally. No vaccination was administered during this study.	Menjugate Comparator [6-12W] Group n=129 Participants Male or female infants 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, in study NCT00866619 (Malaria-055). All vaccines were 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 was given orally. No vaccination was administered during this study.
Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) At Month 3 of Malaria-055	671.8 EU/mL Interval 601.1 to 750.7	599.3 EU/mL Interval 534.0 to 672.5	0.3 EU/mL Interval 0.2 to 0.3	152.9 EU/mL Interval 121.4 to 192.4	169.0 EU/mL Interval 135.9 to 210.0	0.3 EU/mL Interval 0.2 to 0.3
Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) At Month 20 of Malaria-055	38.0 EU/mL Interval 31.1 to 46.5	40.3 EU/mL Interval 33.8 to 48.2	0.3 EU/mL Interval 0.3 to 0.3	4.2 EU/mL Interval 3.2 to 5.6	5.5 EU/mL Interval 4.2 to 7.2	0.3 EU/mL Interval 0.3 to 0.3
Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) At Month 21 of Malaria-055	368.6 EU/mL Interval 329.1 to 412.9	38.8 EU/mL Interval 32.5 to 46.2	0.3 EU/mL Interval 0.3 to 0.3	149.3 EU/mL Interval 119.4 to 186.6	5.3 EU/mL Interval 4.0 to 6.9	0.3 EU/mL Interval 0.3 to 0.4
Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) At Month 32 of Malaria-055	54.7 EU/mL Interval 47.3 to 63.3	21.1 EU/mL Interval 17.6 to 25.2	0.3 EU/mL Interval 0.3 to 0.3	11.7 EU/mL Interval 8.6 to 16.0	3.6 EU/mL Interval 2.9 to 4.6	0.4 EU/mL Interval 0.3 to 0.4
Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) At Year 1 of Malaria-076	20.5 EU/mL Interval 15.3 to 27.5	13.6 EU/mL Interval 10.0 to 18.5	1.3 EU/mL Interval 1.0 to 1.5	5.9 EU/mL Interval 3.8 to 9.1	2.5 EU/mL Interval 1.9 to 3.2	1.4 EU/mL Interval 1.1 to 1.7
Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) At Year 2 of Malaria-076	14.9 EU/mL Interval 12.7 to 17.6	6.8 EU/mL Interval 5.7 to 8.2	1.2 EU/mL Interval 1.1 to 1.4	5.4 EU/mL Interval 4.2 to 6.8	2.4 EU/mL Interval 2.0 to 2.9	1.2 EU/mL Interval 1.1 to 1.3
Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) At Year 3 of Malaria-076	11.2 EU/mL Interval 9.4 to 13.4	5.0 EU/mL Interval 4.2 to 6.0	1.2 EU/mL Interval 1.1 to 1.4	3.9 EU/mL Interval 3.1 to 4.9	2.2 EU/mL Interval 1.9 to 2.6	1.2 EU/mL Interval 1.1 to 1.4

Adverse Events

GSK257049 Group

Serious events: 39 serious events

Other events: 0 other events

Deaths: 5 deaths

GSK257049 Comparator Group

Serious events: 43 serious events

Other events: 0 other events

Deaths: 10 deaths

VeroRab/Menjugate Comparator Group

Serious events: 52 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER