Trial Outcomes & Findings for Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children (NCT NCT01148459)

NCT ID: NCT01148459

Last Updated: 2019-01-16

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 200 participants
• Primary outcome timeframe: During the entire study period (from 30 days before Dose 1 up to Month 14)
• Results posted on: 2019-01-16

Participant Flow

Participant milestones

Measure	GSK257049 Group Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Overall Study STARTED	99	101
Overall Study COMPLETED	87	90
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Measure	GSK257049 Group Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Overall Study Serious Adverse Event	5	4
Overall Study Withdrawal by Subject	1	0
Overall Study Migrated/moved from study area	3	6
Overall Study Lost to Follow-up	2	0
Overall Study Refusal	1	0
Overall Study Failure to comply with study procedures	0	1

Baseline Characteristics

Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children

Baseline characteristics by cohort

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Total n=200 Participants Total of all reporting groups
Age, Continuous	10.1 Months STANDARD_DEVIATION 4.99 • n=5 Participants	9.5 Months STANDARD_DEVIATION 4.63 • n=7 Participants	9.80 Months STANDARD_DEVIATION 4.81 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	45 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	56 Participants n=7 Participants	98 Participants n=5 Participants
Race/Ethnicity, Customized African heritage/African American	99 Participants n=5 Participants	101 Participants n=7 Participants	200 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the entire study period (from 30 days before Dose 1 up to Month 14)

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.

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

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Number of Subjects With Serious Adverse Events (SAEs) Any SAE(s)	41 Participants	37 Participants
Number of Subjects With Serious Adverse Events (SAEs) Any SAE(s) excluding Malaria	41 Participants	37 Participants

SECONDARY outcome

Timeframe: During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 20 millimeters (mm) of injection site.

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	26 Participants	13 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	19 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	6 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	11 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	15 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	8 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	7 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 3	18 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 3	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 3	6 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 3	13 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 3	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	33 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	14 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Across doses	11 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 1	9 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 1	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 1	21 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 1	9 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 1	14 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 1	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	31 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	11 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 2	10 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 2	5 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 2	22 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 2	14 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 2	18 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 2	8 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	34 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	16 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 3	13 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 3	6 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 3	30 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 3	19 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 3	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 3	19 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 3	8 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 3	55 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 3	28 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 3	6 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Across doses	22 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Across doses	46 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Across doses	29 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Across doses	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Across doses	33 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Across doses	17 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	74 Participants	46 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	39 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	10 Participants	6 Participants

SECONDARY outcome

Timeframe: During the 30-day post-vaccination period (up to Day 90)

Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.

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

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	98 Participants	100 Participants

SECONDARY outcome

Timeframe: During the entire study period (from 30 days before vaccine Dose 1 up to Month 14)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

SAEs (excluding malaria, cerebral malaria and P. falciparum parasitemia) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Number of Subjects With Non-malaria Related SAEs	41 Participants	37 Participants

SECONDARY outcome

Timeframe: Prior to vaccination (PRE) and one month post Dose 3 (Month 3)

Population: The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Anti-CS antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The reference seropositivity cut-off value was equal to or above (≥) 0.5 EL.U/mL.

Outcome measures

Measure	GSK257049 Group n=81 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=73 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations Anti-CS, PRE	0.3 EL.U/mL Interval 0.3 to 0.4	0.3 EL.U/mL Interval 0.3 to 0.4
Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations Anti-CS, Month 3	329.2 EL.U/mL Interval 260.6 to 415.8	0.3 EL.U/mL Interval 0.3 to 0.3

SECONDARY outcome

Timeframe: Prior to vaccination (PRE) and one month post Dose 3 (Month 3)

Population: The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in milliinternational units per milliliter (mIU/mL).

Outcome measures

Measure	GSK257049 Group n=77 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=73 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers Anti-HBs, PRE	24.1 mIU/mL Interval 15.2 to 38.1	19.2 mIU/mL Interval 12.1 to 30.6
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers Anti-HBs, Month 3	13637.6 mIU/mL Interval 9579.7 to 19414.5	19.9 mIU/mL Interval 12.4 to 31.9

SECONDARY outcome

Timeframe: 12 months post Dose 3 (Month 14)

Population: The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Anti-CS antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The reference seropositivity cut-off value was equal to or above (≥) 0.5 EL.U/mL.

Outcome measures

Measure	GSK257049 Group n=73 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=67 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Anti-CS Antibody Concentrations	18.4 EL.U/mL Interval 13.3 to 25.5	0.3 EL.U/mL Interval 0.3 to 0.3

SECONDARY outcome

Timeframe: 12 months post Dose 3 (Month 14)

Population: The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in mIU/mL.

Outcome measures

Measure	GSK257049 Group n=70 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=64 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Anti-HBs Antibody Titers	2294.8 mIU/mL Interval 1678.2 to 3138.0	11.8 mIU/mL Interval 7.7 to 18.1

SECONDARY outcome

Timeframe: From Day 0 to Month 14

Population: The analysis was performed on the ATP population for efficacy, which included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.

Primary case definition for clinical malaria: P. falciparum asexual parasitemia > 2500 parasites/μL and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility.

Outcome measures

Measure	GSK257049 Group n=87 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=93 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Number of Episodes With Clinical Malaria Disease According to Primary Case Definition	44 Episodes	76 Episodes

SECONDARY outcome

Timeframe: From Day 0 to Month 14

Population: The analysis was performed on the ATP population for efficacy, which included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.

The number of episodes of severe malaria of primary case definition within and outside risk period. Primary case definition for severe malaria: P. falciparum > 2500 parasites per μL and with one or more marker of disease severity and without a diagnosis of co-morbidity.

Outcome measures

Measure	GSK257049 Group n=87 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=93 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Number of Episodes With Severe Malaria According to Primary Case Definition Episodes outside risk period	0 Episodes	0 Episodes
Number of Episodes With Severe Malaria According to Primary Case Definition Episodes within risk period	0 Episodes	6 Episodes

SECONDARY outcome

Timeframe: 12 months post Dose 3 (Month 14)

Population: The analysis was performed on the ATP population for efficacy, which included all subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.

The number of subjects affected by prevalent asexual P. falciparum parasitemia and prevalent moderate anemia. Moderate anemia = hemoglobin < 8 g/dL.

Outcome measures

Measure	GSK257049 Group n=87 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=93 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia Prevalent parasitemia	7 Participants	3 Participants
Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia Prevalent moderate anemia	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months post Dose 3 (Month 14)

Population: The analysis was performed on children affected by prevalent parasitemia from the ATP population for efficacy, which included subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.

The number of subjects with a positive blood slide for asexual P. falciparum.

Outcome measures

Measure	GSK257049 Group n=7 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=3 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Asexual P. Falciparum Parasitemia Density	7 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 months post Dose 3 (Month 14)

Population: The analysis was performed on the ATP population for efficacy, which included all subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.

The prevalent hemoglobin level in subjects with a positive blood slide is reported as grams per deciliter (g/dl).

Outcome measures

Measure	GSK257049 Group n=87 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=93 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Prevalent Hemoglobin Level	10.3 grams per deciliter Standard Deviation 1.3	10.1 grams per deciliter Standard Deviation 1.2

SECONDARY outcome

Timeframe: At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

The HIV viral load is reported. Detectable HIV viral load: 400 or more copies/mL.

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
HIV Viral Load HIV viral load, Month 3	3125.00 copies/mL Interval 0.0 to 221500.0	583.50 copies/mL Interval 0.0 to 136100.0
HIV Viral Load HIV viral load, Month 8	3790.00 copies/mL Interval 0.0 to 147000.0	400.00 copies/mL Interval 0.0 to 103000.0
HIV Viral Load HIV viral load, PRE	149000.00 copies/mL Interval 7490.0 to 750000.0	157000.00 copies/mL Interval 3630.0 to 750000.0
HIV Viral Load HIV viral load, Month 14	947.00 copies/mL Interval 0.0 to 99400.0	400.00 copies/mL Interval 0.0 to 106000.0

SECONDARY outcome

Timeframe: At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

The percentage of CD4+ cells is reported.

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Percentage of CD4+ Cells CD4+ percentage, PRE	27.55 Percentage Standard Deviation 8.48	26.52 Percentage Standard Deviation 8.48
Percentage of CD4+ Cells CD4+ percentage, Month 3	29.70 Percentage Standard Deviation 9.33	29.92 Percentage Standard Deviation 8.67
Percentage of CD4+ Cells CD4+ percentage, Month 8	32.70 Percentage Standard Deviation 9.70	31.07 Percentage Standard Deviation 9.25
Percentage of CD4+ Cells CD4+ percentage, Month 14	32.80 Percentage Standard Deviation 10.30	31.61 Percentage Standard Deviation 9.56

SECONDARY outcome

Timeframe: At baseline (PRE) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

The CD4+ absolute cell counts are reported.

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
CD4+ Absolute Cell Counts CD4+ absolute cell count, PRE	2075.91 number of cells/μL Standard Deviation 997.81	2086.46 number of cells/μL Standard Deviation 1255.78
CD4+ Absolute Cell Counts CD4+ absolute cell count, Month 3	2150.99 number of cells/μL Standard Deviation 1054.12	2173.04 number of cells/μL Standard Deviation 912.96
CD4+ Absolute Cell Counts CD4+ absolute cell count, Month 8	2261.71 number of cells/μL Standard Deviation 1045.20	2044.51 number of cells/μL Standard Deviation 1014.05
CD4+ Absolute Cell Counts CD4+ absolute cell count, Month 14	1995.36 number of cells/μL Standard Deviation 998.98	2003.70 number of cells/μL Standard Deviation 1027.09

SECONDARY outcome

Timeframe: At baseline (PRE), at study months 1 (Month 1) and 2 (Month 2) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Clinical staging was done at each time point according to the WHO HIV/AIDS clinical staging system. Clinical stages included:

• "Stage 1" (asymptomatic or have persistent generalized lymphadenopathy),
• "Stage 2" (mildly symptomatic stage - presenting with unexplained weight loss of less than 10 percent of total body weight, recurrent respiratory infections or dermatological conditions),
• "Stage 3" (moderately symptomatic stage - presenting with weight loss of greater than 10 percent of total body weight, prolonged unexplained diarrhea or pulmonary tuberculosis, severe systemic bacterial infections or mucocutaneous conditions),
• "Stage 4" (severely symptomatic stage which includes all of the AIDS-defining illnesses) Additional categories included "deceased" and "missing".

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
World Health Organization (WHO) HIV Clinical Classification Progression Missing, Month 12	7 Participants	7 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 1, PRE	81 Participants	82 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 2, PRE	18 Participants	19 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 3, PRE	0 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 4, PRE	0 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Deceased, PRE	0 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 1, Month 1	75 Participants	72 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 2, Month 1	19 Participants	27 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 3, Month 1	2 Participants	1 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 4, Month 1	0 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Deceased, Month 1	2 Participants	1 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Missing, Month 1	1 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 1, Month 2	79 Participants	77 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 2, Month 2	15 Participants	20 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 3, Month 2	1 Participants	2 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 4, Month 2	0 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Deceased, Month 2	2 Participants	1 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Missing, Month 2	2 Participants	1 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 1, Month 3	76 Participants	76 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 2, Month 3	12 Participants	19 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 3, Month 3	4 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 4, Month 3	0 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Deceased, Month 3	2 Participants	2 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Missing, Month 3	5 Participants	4 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 1, Month 8	74 Participants	72 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 2, Month 8	12 Participants	16 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 3, Month 8	0 Participants	3 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 4, Month 8	0 Participants	0 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Deceased, Month 8	4 Participants	3 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Missing, Month 8	9 Participants	7 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 1, Month 12	74 Participants	69 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 2, Month 12	10 Participants	18 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 3, Month 12	3 Participants	1 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Stage 4, Month 12	0 Participants	2 Participants
World Health Organization (WHO) HIV Clinical Classification Progression Deceased, Month 12	5 Participants	4 Participants

SECONDARY outcome

Timeframe: At baseline (PRE), at Month 3 and at study end (Month 14)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

The following growth parameters: weight, age/length and middle upper arm circumference for age z-score are reported.

Outcome measures

Measure	GSK257049 Group n=99 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 Participants Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Height for age z-score, Month 3	-1.91 age z-score Standard Deviation 1.14	-2.12 age z-score Standard Deviation 1.16
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Height for age z-score, PRE	-1.67 age z-score Standard Deviation 1.20	-1.98 age z-score Standard Deviation 1.37
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Weight for age z-score, PRE	-1.38 age z-score Standard Deviation 1.13	-1.67 age z-score Standard Deviation 1.19
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Mid upper arm circumference z-score, PRE	-0.65 age z-score Standard Deviation 1.13	-0.90 age z-score Standard Deviation 1.19
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Weight for age z-score, Month 3	-1.32 age z-score Standard Deviation 1.10	-1.55 age z-score Standard Deviation 1.09
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Mid upper arm circumference z-score, Month 3	-0.39 age z-score Standard Deviation 1.03	-0.65 age z-score Standard Deviation 1.04
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Height for age z-score, Month 14	-1.74 age z-score Standard Deviation 1.19	-2.26 age z-score Standard Deviation 1.18
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Weight for age z-score, Month 14	-1.10 age z-score Standard Deviation 1.14	-1.47 age z-score Standard Deviation 1.02
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score Mid upper arm circumference z-score, Month 14	-0.29 age z-score Standard Deviation 1.13	-0.51 age z-score Standard Deviation 0.93

Adverse Events

GSK257049 Group

Serious events: 41 serious events

Other events: 98 other events

Deaths: 5 deaths

Verorab Group

Serious events: 37 serious events

Other events: 99 other events

Deaths: 4 deaths

Serious adverse events

Measure	GSK257049 Group n=99 participants at risk Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 participants at risk Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Infections and infestations Pneumonia	23.2% 23/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	22.8% 23/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Gastroenteritis	21.2% 21/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	18.8% 19/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Nervous system disorders Febrile convulsion	10.1% 10/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	12.9% 13/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Malaria	5.1% 5/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	9.9% 10/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Salmonella sepsis	7.1% 7/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	5.9% 6/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Metabolism and nutrition disorders Malnutrition	7.1% 7/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	5.0% 5/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Oral candidiasis	5.1% 5/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	5.0% 5/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Blood and lymphatic system disorders Anaemia	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	6.9% 7/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Otitis media	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	4.0% 4/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Pulmonary tuberculosis	2.0% 2/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	2.0% 2/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Urinary tract infection	2.0% 2/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	2.0% 2/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Measles	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	3.0% 3/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Pneumococcal sepsis	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	3.0% 3/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Bronchiolitis	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	2.0% 2/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Nervous system disorders Convulsion	2.0% 2/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Metabolism and nutrition disorders Dehydration	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	2.0% 2/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Helminthic infection	2.0% 2/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Tuberculosis	2.0% 2/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Abscess	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Amoebiasis	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Cellulitis	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Gastrointestinal disorders Enteritis	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Gastroenteritis salmonella	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Hepatobiliary disorders Hepatitis	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Metabolism and nutrition disorders Kwashiorkor	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Meningitis haemophilus	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Mycobacterium avium complex infection	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Oropharyngeal candidiasis	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Pneumocystis jiroveci pneumonia	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
General disorders Pyrexia	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Sepsis	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Upper respiratory tract infection	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Varicella	1.0% 1/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.00% 0/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Viral infection	0.00% 0/99 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	0.99% 1/101 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).

Other adverse events

Measure	GSK257049 Group n=99 participants at risk Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.	Verorab Group n=101 participants at risk Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60.
Blood and lymphatic system disorders Anaemia	16.2% 16/99 • Number of events 17 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	16.8% 17/101 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Body tinea	6.1% 6/99 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	3.0% 3/101 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	8.1% 8/99 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	13.9% 14/101 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Eye disorders Conjunctivitis	13.1% 13/99 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	11.9% 12/101 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Respiratory, thoracic and mediastinal disorders Cough	6.1% 6/99 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	3.0% 3/101 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Metabolism and nutrition disorders Decreased appetite	33.3% 33/99 • Number of events 51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	22.8% 23/101 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Skin and subcutaneous tissue disorders Dermatitis diaper	2.0% 2/99 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	5.0% 5/101 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Skin and subcutaneous tissue disorders Eczema	19.2% 19/99 • Number of events 26 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	21.8% 22/101 • Number of events 32 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Gastrointestinal disorders Enteritis	26.3% 26/99 • Number of events 33 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	26.7% 27/101 • Number of events 35 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Skin and subcutaneous tissue disorders Erythema	14.1% 14/99 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	8.9% 9/101 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Gastroenteritis	38.4% 38/99 • Number of events 58 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	40.6% 41/101 • Number of events 56 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Impetigo	9.1% 9/99 • Number of events 9 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	6.9% 7/101 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Psychiatric disorders Irritability	46.5% 46/99 • Number of events 73 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	24.8% 25/101 • Number of events 32 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Malaria	22.2% 22/99 • Number of events 29 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	19.8% 20/101 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Metabolism and nutrition disorders Malnutrition	2.0% 2/99 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	5.9% 6/101 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Oral candidiasis	11.1% 11/99 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	18.8% 19/101 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Otitis media	14.1% 14/99 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	14.9% 15/101 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
General disorders Pain	33.3% 33/99 • Number of events 52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	17.8% 18/101 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Pneumonia	25.3% 25/99 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	20.8% 21/101 • Number of events 28 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
General disorders Pyrexia	76.8% 76/99 • Number of events 128 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	49.5% 50/101 • Number of events 67 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Skin and subcutaneous tissue disorders Rash	5.1% 5/99 • Number of events 5 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	8.9% 9/101 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Skin and subcutaneous tissue disorders Rash papular	7.1% 7/99 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	9.9% 10/101 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Skin and subcutaneous tissue disorders Rash pruritic	5.1% 5/99 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	8.9% 9/101 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Rhinitis	25.3% 25/99 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	17.8% 18/101 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Nervous system disorders Somnolence	22.2% 22/99 • Number of events 32 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	14.9% 15/101 • Number of events 15 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
General disorders Swelling	26.3% 26/99 • Number of events 31 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	12.9% 13/101 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Infections and infestations Upper respiratory tract infection	74.7% 74/99 • Number of events 127 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	78.2% 79/101 • Number of events 146 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).
Gastrointestinal disorders Vomiting	5.1% 5/99 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).	5.9% 6/101 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post vaccination period; SAEs: during the entire study period (from Day 0 up to Month 14).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER