Trial Outcomes & Findings for Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children. (NCT NCT00380393)

Last Updated: 2018-07-03

Results Overview

The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (\>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

894 participants

Primary outcome timeframe

Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)

Results posted on

2018-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	GSK257049 Group Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Month 8 (Cross-sectional Visit) STARTED	447	447
Month 8 (Cross-sectional Visit) COMPLETED	398	407
Month 8 (Cross-sectional Visit) NOT COMPLETED	49	40
Month 14 STARTED	447	447
Month 14 COMPLETED	390	391
Month 14 NOT COMPLETED	57	56

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK257049 Group Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Month 8 (Cross-sectional Visit) Withdrawal by Subject	6	5
Month 8 (Cross-sectional Visit) Lost to Follow-up	0	1
Month 8 (Cross-sectional Visit) Migrated/moved from study area	37	29
Month 8 (Cross-sectional Visit) Serious Adverse Event	1	1
Month 8 (Cross-sectional Visit) Others	5	4
Month 14 Withdrawal by Subject	9	7
Month 14 Death	1	0
Month 14 Lost to Follow-up	0	1
Month 14 Migrated/moved from study area	39	42
Month 14 Protocol Violation	2	0
Month 14 Others	6	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Total n=894 Participants Total of all reporting groups
Age, Continuous	11.4 Months STANDARD_DEVIATION 3.6 • n=447 Participants	11.4 Months STANDARD_DEVIATION 3.4 • n=447 Participants	11.4 Months STANDARD_DEVIATION 3.5 • n=894 Participants
Sex: Female, Male Female	229 Participants n=447 Participants	222 Participants n=447 Participants	451 Participants n=894 Participants
Sex: Female, Male Male	218 Participants n=447 Participants	225 Participants n=447 Participants	443 Participants n=894 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)

Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=415 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=420 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Frequency of First Case of Malaria Meeting the Primary Case Definition With estimate of VE adjusted for covariates	244.77 PYAR	238.51 PYAR
Frequency of First Case of Malaria Meeting the Primary Case Definition With estimate of VE unadjusted for covariates	249.23 PYAR	242.06 PYAR

SECONDARY outcome

Timeframe: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)

Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.

The first case of malaria meeting the secondary case definition was defined as the first or only episodes with the presence of P.falciparum asexual parasitemia \> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=415 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=420 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Frequency of First Case Malaria Meeting the Secondary Case Definition With estimate of VE adjusted for covariates	244.72 PYAR	237.21 PYAR
Frequency of First Case Malaria Meeting the Secondary Case Definition With estimate of VE unadjusted for covariates	249.17 PYAR	240.76 PYAR

SECONDARY outcome

Timeframe: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)

Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.

Multiple episodes of malaria meeting the primary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \> 25000 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of primary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=415 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=420 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Multiple Events of Malaria Meeting the Primary Case Definition With estimate of VE adjusted for covariates	253.69 PYAR	255.36 PYAR
Multiple Events of Malaria Meeting the Primary Case Definition With estimate of VE unadjusted for covariates	258.15 PYAR	259.61 PYAR

SECONDARY outcome

Timeframe: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)

Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.

Multiple episodes of malaria meeting the secondary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of secondary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=415 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=420 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Multiple Events of Malaria Meeting the Secondary Case Definition With estimate of VE adjusted for covariates	253.62 PYAR	255.06 PYAR
Multiple Events of Malaria Meeting the Secondary Case Definition With estimate of VE unadjusted for covariates	258.07 PYAR	259.31 PYAR

SECONDARY outcome

Timeframe: At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)

Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=380 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=390 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects Positive for P. Falciparum Parasitaemia	7 Participants	11 Participants

SECONDARY outcome

Timeframe: At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)

Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.

Estimates of asexual P. falciparum parasite density were made at the investigator's sites according to laboratory standard operating procedures. Parasite density was presented as a geometric mean (GMean), expressed in parasite per microliters (μL).

Outcome measures

Outcome measures
Measure	GSK257049 Group n=380 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=390 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Geometric Mean Density of Asexual P. Falciparum Parasite	1020 parasites/μL Interval 135.0 to 7720.0	3486 parasites/μL Interval 557.0 to 21813.0

SECONDARY outcome

Timeframe: At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)

Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.

Haemoglobin values are expressed in grams per deciliter (g/dL).

Outcome measures

Outcome measures
Measure	GSK257049 Group n=379 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=388 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Haemoglobin Values at Cross-Sectional Visit	10.32 g/dL Standard Deviation 1.01	10.37 g/dL Standard Deviation 1.03

SECONDARY outcome

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

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.

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

Outcome measures

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling Pain, Dose 2	6 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling Pain, Dose 3	8 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	51 Participants	39 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 Swelling Pain, Dose 1	20 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling 3 Pain, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	45 Participants	38 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 Swelling 3 Pain, Dose 2	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 3	76 Participants	80 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling 3 Pain, Dose 3	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	143 Participants	130 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling Pain, Across doses	30 Participants	13 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling 3 Pain, Across doses	3 Participants	0 Participants

SECONDARY outcome

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

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.

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

Outcome measures

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
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 Related Irritability, Dose 1	17 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	49 Participants	133 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 1	26 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 1	34 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 1	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 1	14 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 2	22 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 2	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 2	22 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	56 Participants	159 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	3 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	51 Participants	156 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 2	16 Participants	7 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 Related Irritability, Dose 2	14 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 2	24 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 2	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 2	12 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 3	15 Participants	11 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 Related Drowsiness, Dose 3	15 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 3	38 Participants	112 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 3	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 3	32 Participants	107 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 3	17 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 3	13 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 3	6 Participants	2 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 Related Loss of appetite, Dose 3	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Across Doses	66 Participants	59 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Across Doses	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Across Doses	55 Participants	56 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across Doses	125 Participants	268 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across Doses	5 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across Doses	111 Participants	262 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Across Doses	45 Participants	19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Across Doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Across Doses	33 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Across Doses	54 Participants	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Across Doses	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Across Doses	28 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 1	44 Participants	28 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 Related Drowsiness, Dose 1	32 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	55 Participants	138 Participants

SECONDARY outcome

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

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

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

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	349 Participants	332 Participants

SECONDARY outcome

Timeframe: Throughout the study period (Day 0 - Month 14)

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

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

Outcome measures

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects With Serious Adverse Events (SAEs)	51 Participants	88 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Definitions for toxicity grading for hemoglobin were: Normal Hemoglobin = equal to or above (≥) 8.0 g/dL; Grade 1 Hemoglobin = under (\<) 8.0 g/dL and above (\>) 6.0 g/dL.; Grade 2 Hemoglobin = under (\<) 6.0 g/dL.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Day 0 · Normal	445 Participants	446 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 1	1 Participants	1 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 2	1 Participants	0 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Day 0 · Missing	0 Participants	0 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Month 3 · Normal	410 Participants	413 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 1	7 Participants	10 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 2	0 Participants	0 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Month 3 · Missing	30 Participants	24 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Normal	391 Participants	397 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 1	6 Participants	8 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 2	0 Participants	0 Participants
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Missing	50 Participants	42 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Definitions for toxicity grading for WBC were: Normal WBC = ≥ 4.0 x 10\^3 cells per microliters (cells/μL) or \< 17 x 10\^3 cells /μL; Grade 1 WBC = 2.5 to 4.0 x 10\^3 cells/μL.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Day 0 · Normal	447 Participants	447 Participants
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 1	0 Participants	0 Participants
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Day 0 · Missing	0 Participants	0 Participants
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Month 3 · Normal	416 Participants	422 Participants
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 1	0 Participants	1 Participants
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Month 3 · Missing	31 Participants	24 Participants
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Normal	395 Participants	405 Participants
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 1	0 Participants	0 Participants
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Missing	52 Participants	42 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Definitions for toxicity grading for platelets were: Normal Platelets = ≥ 75 x 10\^3 cells/μL; Grade 1 Platelets = 50 to 74 x 10\^3 /μL; Grade 2 Platelets = 25 to 49 x 10\^3 /μL; Grade 3 Platelets = \< 25 x 10\^3 /μL.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Day 0 · Normal	445 Participants	447 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 1	1 Participants	0 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 2	0 Participants	0 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 3	0 Participants	0 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Day 0 · Missing	1 Participants	0 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Month 3 · Normal	414 Participants	417 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 1	1 Participants	0 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 2	2 Participants	4 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 3	0 Participants	1 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Month 3 · Missing	30 Participants	25 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Normal	386 Participants	396 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 1	4 Participants	1 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 2	1 Participants	0 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 3	0 Participants	0 Participants
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Missing	56 Participants	50 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Definition for toxicity grading for ALT were: Normal ALT = ≤ 60 international units per liter (IU/L); Grade 1 ALT = 1.1 to 2.5 x Upper Limit of Normal (ULN); Grade 2 ALT = 2.6 to 5.0 x ULN.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Month 3 · Missing	33 Participants	24 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Normal	393 Participants	397 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 1	5 Participants	8 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 2	0 Participants	1 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Missing	49 Participants	41 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Day 0 · Normal	446 Participants	447 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 1	1 Participants	0 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 2	0 Participants	0 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Day 0 · Missing	0 Participants	0 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Month 3 · Normal	413 Participants	420 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 1	1 Participants	2 Participants
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 2	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)

Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Definition for toxicity grading for creatinine were: Normal Creatinine = ≤ 60 micromols per liter (μmol/L); Grade 1 Creatinine = 1.1 to 1.5 x ULN; Grade 2 Creatinine = 1.6 to 3.0 x ULN.

Outcome measures

Outcome measures
Measure	GSK257049 Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Day 0 · Normal	447 Participants	447 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 1	0 Participants	0 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Day 0 · Grade 2	0 Participants	0 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Day 0 · Missing	0 Participants	0 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Month 3 · Normal	415 Participants	422 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 1	0 Participants	0 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Month 3 · Grade 2	0 Participants	0 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Month 3 · Missing	32 Participants	25 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Normal	397 Participants	405 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 1	1 Participants	0 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Grade 2	0 Participants	1 Participants
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades At Cross-sectional Visit · Missing	49 Participants	41 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)

Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	GSK257049 Group n=411 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=419 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) At Day 0	0.3 EU/mL Interval 0.3 to 0.3	0.3 EU/mL Interval 0.3 to 0.3
Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) At Month 3	539.6 EU/mL Interval 500.7 to 581.6	0.3 EU/mL Interval 0.3 to 0.3
Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) At Cross-sectional Visit	71.9 EU/mL Interval 65.7 to 78.6	0.3 EU/mL Interval 0.2 to 0.3

SECONDARY outcome

Timeframe: At Day 0 and at Month 3

Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	GSK257049 Group n=410 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=419 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs) At Day 0	155.4 EU/mL Interval 134.6 to 179.5	187.4 EU/mL Interval 161.8 to 217.0
Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs) At Month 3	46776.3 EU/mL Interval 39018.3 to 56076.8	168.0 EU/mL Interval 145.6 to 193.8

SECONDARY outcome

Timeframe: Prior to vaccination (Day 0)

T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \[IL-2\], tumor-necrosis factor-alpha \[TNF-α\] and interferon-gamma \[IFN-γ\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).

Outcome measures

Outcome measures
Measure	GSK257049 Group n=168 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=183 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells CD4-IFN-γ	15 cells/million Interval 1.0 to 55.0	14 cells/million Interval 1.0 to 56.0
Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells CD4-IL-2	111 cells/million Interval 59.0 to 166.0	113 cells/million Interval 53.0 to 212.0
Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells CD4-TNF-α	94 cells/million Interval 40.0 to 218.0	92 cells/million Interval 40.0 to 238.0

SECONDARY outcome

Timeframe: Prior to vaccination (Day 0)

Outcome measures

Outcome measures
Measure	GSK257049 Group n=161 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=165 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells CD8-IFN-γ	1 cells/million Interval 1.0 to 56.0	37 cells/million Interval 1.0 to 90.0
Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells CD8-IL-2	219 cells/million Interval 117.0 to 417.0	222 cells/million Interval 98.0 to 395.0
Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells CD8-TNF-α	100 cells/million Interval 35.0 to 254.0	82 cells/million Interval 37.0 to 203.0

SECONDARY outcome

Timeframe: At Month 3

Outcome measures

Outcome measures
Measure	GSK257049 Group n=156 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=169 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells CD4-IFN-γ	33 cells/million Interval 13.0 to 94.0	13 cells/million Interval 1.0 to 79.0
Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells CD4-IL-2	648 cells/million Interval 359.0 to 1342.0	139 cells/million Interval 66.0 to 463.0
Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells CD4-TNF-α	416 cells/million Interval 225.0 to 755.0	172 cells/million Interval 66.0 to 460.0

SECONDARY outcome

Timeframe: At Month 3

Outcome measures

Outcome measures
Measure	GSK257049 Group n=143 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=156 Participants Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells CD8-IFN-γ	36 cells/million Interval 1.0 to 158.0	32 cells/million Interval 1.0 to 160.0
Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells CD8-IL-2	248 cells/million Interval 131.0 to 428.0	219 cells/million Interval 96.0 to 459.0
Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells CD8-TNF-α	201 cells/million Interval 104.0 to 407.0	185 cells/million Interval 68.0 to 390.0

Adverse Events

GSK257049 Group

Serious events: 51 serious events

Other events: 385 other events

Deaths: 1 deaths

Rabipur Group

Serious events: 88 serious events

Other events: 396 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK257049 Group n=447 participants at risk Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.	Rabipur Group n=447 participants at risk Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Metabolism and nutrition disorders Decreased appetite	12.1% 54/447 • Number of events 64 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	8.9% 40/447 • Number of events 43 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Gastroenteritis	22.6% 101/447 • Number of events 120 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	18.1% 81/447 • Number of events 90 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Impetigo	6.0% 27/447 • Number of events 28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	4.3% 19/447 • Number of events 20 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Psychiatric disorders Irritability	10.1% 45/447 • Number of events 59 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	4.3% 19/447 • Number of events 21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Lower respiratory tract infection	6.0% 27/447 • Number of events 27 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	6.3% 28/447 • Number of events 28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
General disorders Pain	32.0% 143/447 • Number of events 172 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	29.1% 130/447 • Number of events 157 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Pneumonia	33.3% 149/447 • Number of events 195 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	31.5% 141/447 • Number of events 188 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
General disorders Pyrexia	28.0% 125/447 • Number of events 149 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	60.0% 268/447 • Number of events 409 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Rhinitis	6.0% 27/447 • Number of events 28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	4.0% 18/447 • Number of events 20 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Nervous system disorders Somnolence	14.8% 66/447 • Number of events 81 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	13.2% 59/447 • Number of events 64 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
General disorders Swelling	6.7% 30/447 • Number of events 34 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	3.1% 14/447 • Number of events 17 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).
Infections and infestations Upper respiratory tract infection	18.1% 81/447 • Number of events 96 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - Month 14).	12.5% 56/447 • Number of events 59 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6), Unsolicited AEs: during the 30-day post-vaccination period(Days 0-29), SAEs: during the entire study period (Day 0 - 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