Trial Outcomes & Findings for Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults (NCT NCT03162614)

NCT ID: NCT03162614

Last Updated: 2020-10-27

Results Overview

Occurrence of P. falciparum parasitemia (defined by a positive blood slide) following sporozoite challenge. Post-challenge, parasitemia was determined by microscopy of Giemsa-stained thick blood films (smear). Microscopy was performed on thick smears using a validated standard operation procedure. For the analysis of proportion affected (relative risk), all subjects included in the analysis were considered at risk of infection and no censoring or elimination was applied for subjects not completing the entire protocol defined post challenge follow-up (Day 315 - 28 days post challenge).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 154 participants
• Primary outcome timeframe: Following sporozoite challenge starting 3 months after the last vaccine dose (Day 287) for up to 28 days post-challenge (Day 315).
• Results posted on: 2020-10-27

Participant Flow

Participant milestones

Measure	AduFx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Study STARTED	26	26	26	26	26	24
Overall Study COMPLETED	20	21	22	19	21	24
Overall Study NOT COMPLETED	6	5	4	7	5	0

Reasons for withdrawal

Measure	AduFx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Overall Study Lost to Follow-up	2	1	1	1	2	0
Overall Study Protocol Violation	0	1	0	1	0	0
Overall Study Withdrawal by Subject	2	1	1	1	0	0
Overall Study Missed vaccination, exclusion criteria	2	2	2	4	3	0

Baseline Characteristics

Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults

Baseline characteristics by cohort

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge	Total n=154 Participants Total of all reporting groups
Age, Continuous	31.7 Years STANDARD_DEVIATION 8.4 • n=5 Participants	30.8 Years STANDARD_DEVIATION 9.6 • n=7 Participants	32.0 Years STANDARD_DEVIATION 10.4 • n=5 Participants	32.4 Years STANDARD_DEVIATION 10.9 • n=4 Participants	32.2 Years STANDARD_DEVIATION 10.3 • n=21 Participants	34.6 Years STANDARD_DEVIATION 11.9 • n=8 Participants	32.3 Years STANDARD_DEVIATION 10.2 • n=8 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=8 Participants	57 Participants n=8 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	22 Participants n=4 Participants	16 Participants n=21 Participants	14 Participants n=8 Participants	97 Participants n=8 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants
Race/Ethnicity, Customized Black Or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=8 Participants	48 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Other, Not Specified	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=8 Participants	10 Participants n=8 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	14 Participants n=21 Participants	14 Participants n=8 Participants	86 Participants n=8 Participants

PRIMARY outcome

Timeframe: Following sporozoite challenge starting 3 months after the last vaccine dose (Day 287) for up to 28 days post-challenge (Day 315).

Population: Analysis was performed on Per-Protocol Set, which included all subjects fulfilling eligibility criteria who received vaccinations according to protocol procedures, did not report any underlying medical condition influencing the efficacy response, had available data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.

Occurrence of P. falciparum parasitemia (defined by a positive blood slide) following sporozoite challenge. Post-challenge, parasitemia was determined by microscopy of Giemsa-stained thick blood films (smear). Microscopy was performed on thick smears using a validated standard operation procedure. For the analysis of proportion affected (relative risk), all subjects included in the analysis were considered at risk of infection and no censoring or elimination was applied for subjects not completing the entire protocol defined post challenge follow-up (Day 315 - 28 days post challenge).

Outcome measures

Measure	AduFx Group n=20 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=21 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=22 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=20 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=21 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=22 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With at Least One Occurrence of Plasmodium Falciparum (P. Falciparum) Parasitemia for Each Vaccination Schedule Versus Infectivity Controls	9 Participants	5 Participants	8 Participants	9 Participants	15 Participants	22 Participants

SECONDARY outcome

Timeframe: Following sporozoite challenge starting 3 months after the last vaccine dose (at Day 287) for up to 28 days post-challenge (at Day 315).

Population: Analysis was performed on Per-Protocol Set, which included all subjects fulfilling eligibility criteria who received vaccinations according to protocol procedures, did not report any underlying medical condition influencing the efficacy response, had available data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.

For the analyses of time to onset of parasitemia, time at risk started on first day of challenge. Time at risk was censored on Day 315 (28 days post challenge), drop-out date, start date of antimalarial treatment or date meeting an endpoint, whichever occurs first.

Outcome measures

Measure	AduFx Group n=9 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=5 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=8 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=9 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=15 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=22 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Time to Onset of P. Falciparum Parasitemia After Sporozoite Challenge for Each Vaccination Schedule	14.8 Days Standard Deviation 1.2	14.6 Days Standard Deviation 1.1	14.3 Days Standard Deviation 2.0	14.9 Days Standard Deviation 2.1	14.2 Days Standard Deviation 2.4	12.7 Days Standard Deviation 1.9

SECONDARY outcome

Timeframe: At Day 1, Day 59, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx Groups. At Day 1, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from Adu1Fx Group

Population: Analysis was performed on subjects fulfilling eligibility criteria, who received study vaccination according to protocol procedures (therefore, not on subjects from the Control Group), did not report any medical condition influencing the efficacy response, had data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.

Anti-CS antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-linked immunosorbent assay Unit per milliliter (EU/mL). The cut-off for the assay was 1.9 EU/mL. The GMC calculations were performed by taking the anti-log of the mean of the log transformations (base 10). Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off (=1.0) for the purpose of GMC calculation.

Outcome measures

Measure	AduFx Group n=20 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=21 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=22 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=20 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=21 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations At Day 315	56.6 EU/mL Interval 32.5 to 98.4	51 EU/mL Interval 33.3 to 78.0	31.3 EU/mL Interval 21.2 to 46.3	44.1 EU/mL Interval 27.8 to 70.1	10.6 EU/mL Interval 5.2 to 21.5	—
Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations At Day 377	43.7 EU/mL Interval 24.9 to 76.8	38.1 EU/mL Interval 24.3 to 59.8	25 EU/mL Interval 16.5 to 37.9	31.7 EU/mL Interval 19.6 to 51.3	9.5 EU/mL Interval 4.8 to 19.0	—
Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations At Day 1	1 EU/mL Interval 1.0 to 1.0	1 EU/mL Interval 1.0 to 1.0	1 EU/mL Interval 1.0 to 1.0	1 EU/mL Interval 1.0 to 1.0	1 EU/mL Interval 1.0 to 1.0	—
Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations At Day 59	108.2 EU/mL Interval 70.1 to 167.0	107.8 EU/mL Interval 73.0 to 159.1	53.8 EU/mL Interval 39.0 to 74.1	61.7 EU/mL Interval 47.6 to 79.9	—	—
Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations At Day 197	30 EU/mL Interval 17.9 to 50.5	39.3 EU/mL Interval 23.8 to 64.8	15.1 EU/mL Interval 9.3 to 24.5	19.4 EU/mL Interval 13.2 to 28.5	3.8 EU/mL Interval 2.0 to 7.2	—
Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations At Day 227	85.9 EU/mL Interval 50.8 to 145.5	79.8 EU/mL Interval 54.7 to 116.6	50.2 EU/mL Interval 35.5 to 70.9	64 EU/mL Interval 42.8 to 95.8	22.1 EU/mL Interval 12.0 to 40.8	—
Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations At Day 287	61.4 EU/mL Interval 34.7 to 108.8	57.6 EU/mL Interval 38.2 to 87.1	34.4 EU/mL Interval 23.1 to 51.1	38.1 EU/mL Interval 20.8 to 69.9	12.3 EU/mL Interval 6.2 to 24.4	—

SECONDARY outcome

Timeframe: At Day 1, Day 59, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx Groups. At Day 1, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from Adu1Fx Group

Population: Analysis was performed on subjects fulfilling eligibility criteria, who received study vaccination according to protocol procedures (therefore, not on subjects from the Control Group), did not report any medical condition influencing the efficacy response, had data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.

Anti-HBs IgG antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milli-International Unit per milliliter (mIU/ml). The cut-off for the assay was 6.2 mIU/mL.

Outcome measures

Measure	AduFx Group n=20 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=21 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=22 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=20 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=21 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations At Day 1	44.1 mIU/mL Interval 15.6 to 124.3	68.8 mIU/mL Interval 20.4 to 231.7	45.7 mIU/mL Interval 15.2 to 137.5	21.8 mIU/mL Interval 9.0 to 52.6	16 mIU/mL Interval 6.5 to 39.6	—
Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations At Day 59	42616.7 mIU/mL Interval 12325.1 to 147356.7	28894.8 mIU/mL Interval 8705.8 to 95903.3	26149.3 mIU/mL Interval 8588.7 to 79615.2	14710.6 mIU/mL Interval 3837.0 to 56398.8	—	—
Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations At Day 197	19369.3 mIU/mL Interval 8325.5 to 45062.6	15358.8 mIU/mL Interval 5971.2 to 39505.1	11269.1 mIU/mL Interval 4892.1 to 25958.8	6846.7 mIU/mL Interval 2273.5 to 20618.8	2031.7 mIU/mL Interval 715.9 to 5766.4	—
Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations At Day 227	45959.9 mIU/mL Interval 27093.8 to 77962.8	30994.5 mIU/mL Interval 15352.8 to 62572.4	28560.6 mIU/mL Interval 15532.4 to 52516.4	26717 mIU/mL Interval 12916.3 to 55263.3	35620.9 mIU/mL Interval 22337.4 to 56803.7	—
Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations At Day 287	36266.3 mIU/mL Interval 21828.7 to 60252.9	20712.2 mIU/mL Interval 10050.4 to 42684.5	19126.1 mIU/mL Interval 9889.0 to 36991.5	13911.3 mIU/mL Interval 4939.4 to 39179.9	16376.8 mIU/mL Interval 9798.1 to 27372.8	—
Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations At Day 315	33027.7 mIU/mL Interval 19159.7 to 56933.4	18527.8 mIU/mL Interval 8862.8 to 38732.5	17465.5 mIU/mL Interval 8798.2 to 34671.2	16685 mIU/mL Interval 8192.0 to 33982.9	12609.9 mIU/mL Interval 7499.3 to 21203.5	—
Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations At Day 377	27823 mIU/mL Interval 15910.1 to 48655.8	15083.7 mIU/mL Interval 6953.8 to 32718.4	13716 mIU/mL Interval 6456.7 to 29136.9	11257.6 mIU/mL Interval 5164.7 to 24538.5	10975.2 mIU/mL Interval 5889.9 to 20451.3	—

SECONDARY outcome

Timeframe: Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3.

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

Solicited local symptoms assessed are pain, redness and swelling. Any occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom greater than (>) 0 millimeter (mm).

Outcome measures

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=25 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Any Solicited Local Symptoms Swelling, dose 1	5 Participants	12 Participants	3 Participants	4 Participants	5 Participants	—
Number of Subjects With Any Solicited Local Symptoms Pain, dose 2	20 Participants	16 Participants	20 Participants	12 Participants	—	—
Number of Subjects With Any Solicited Local Symptoms Pain, dose 3	11 Participants	12 Participants	13 Participants	16 Participants	15 Participants	—
Number of Subjects With Any Solicited Local Symptoms Redness, dose 3	7 Participants	10 Participants	10 Participants	11 Participants	6 Participants	—
Number of Subjects With Any Solicited Local Symptoms Swelling, dose 3	3 Participants	6 Participants	5 Participants	3 Participants	3 Participants	—
Number of Subjects With Any Solicited Local Symptoms Pain, dose 1	23 Participants	21 Participants	22 Participants	22 Participants	19 Participants	—
Number of Subjects With Any Solicited Local Symptoms Redness, dose 1	8 Participants	11 Participants	4 Participants	8 Participants	9 Participants	—
Number of Subjects With Any Solicited Local Symptoms Redness, dose 2	8 Participants	10 Participants	5 Participants	4 Participants	—	—
Number of Subjects With Any Solicited Local Symptoms Swelling, dose 2	5 Participants	8 Participants	6 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3.

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

Solicited general symptoms assessed are fatigue, gastrointestinal symptoms, headache and fever. Any occurrence of symptom regardless of intensity grade. Fever was defined as temperature equal or greater than (≥) 37.5 degrees Celsius (°C) for oral route, axillary or tympanic route or 38.0°C for rectal route.

Outcome measures

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=25 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Any Solicited General Symptoms Fatigue, dose 1	13 Participants	14 Participants	13 Participants	10 Participants	11 Participants	—
Number of Subjects With Any Solicited General Symptoms Gastrointestinal symptoms, dose 1	5 Participants	8 Participants	5 Participants	4 Participants	6 Participants	—
Number of Subjects With Any Solicited General Symptoms Fatigue, dose 2	11 Participants	12 Participants	10 Participants	6 Participants	—	—
Number of Subjects With Any Solicited General Symptoms Fever, dose 3	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	—
Number of Subjects With Any Solicited General Symptoms Headache, dose 1	15 Participants	14 Participants	10 Participants	12 Participants	9 Participants	—
Number of Subjects With Any Solicited General Symptoms Fever, dose 1	3 Participants	6 Participants	2 Participants	3 Participants	3 Participants	—
Number of Subjects With Any Solicited General Symptoms Gastrointestinal symptoms, dose 2	3 Participants	6 Participants	7 Participants	3 Participants	—	—
Number of Subjects With Any Solicited General Symptoms Headache, dose 2	13 Participants	14 Participants	11 Participants	6 Participants	—	—
Number of Subjects With Any Solicited General Symptoms Fever, dose 2	6 Participants	6 Participants	3 Participants	1 Participants	—	—
Number of Subjects With Any Solicited General Symptoms Fatigue, dose 3	4 Participants	6 Participants	8 Participants	11 Participants	8 Participants	—
Number of Subjects With Any Solicited General Symptoms Gastrointestinal symptoms, dose 3	4 Participants	2 Participants	6 Participants	0 Participants	5 Participants	—
Number of Subjects With Any Solicited General Symptoms Headache, dose 3	6 Participants	7 Participants	6 Participants	9 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Within the 30-day period (Days 1-30), after any vaccination (across doses)

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

An unsolicited adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event is any event 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.

Outcome measures

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination	18 Participants	18 Participants	15 Participants	17 Participants	10 Participants	—

SECONDARY outcome

Timeframe: Within the 30-day (Days 1-30) period post-challenge

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Any Unsolicited AEs After Challenge	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 30-day period (Days 1-30) after any vaccination (across doses)

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

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	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Any, Fatal or Related Serious Adverse Events (SAEs) After Each Vaccination	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From Day 1 up to study conclusion (Day 377)

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

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	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Any, Fatal or Related SAEs During the Whole Study Period	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to study conclusion (Day 377)

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Any AE and SAE Leading to Withdrawal From Further Vaccination	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to study conclusion (Day 377)

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

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

Outcome measures

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Potential Immune Mediated Diseases (pIMDs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 up to study conclusion (Day 377)

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

Meningitis is to be reported as an adverse event of specific interest and tabulated per study group.

Outcome measures

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Meningitis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Visit 1 Screening (Day -89 to Day 1), Day 36, Day 59, Day 204, Day 227, between Day 292 & Day 313, and Day 315 for each vaccinated subject.For Infectivity Control subjects at Visit 1b Screening (Day 231 to Day 287),between Day 292 & Day 313,and Day 315

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

Biochemistry (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST] and creatinine) and hematological (hemoglobin, platelets, White Blood Cells [WBC] decrease and WBC increase) laboratory values were presented according to toxicity grading scales (Grade 0 [GR0], Grade 1 [GR1], Grade 2 [GR2] Grade 3 [GR3]) and tabulated by group. Grading scale is taken from the [FDA guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (September 2007)].

Outcome measures

Measure	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, SCR, Gr2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D227, Gr0	23 Participants	23 Participants	24 Participants	24 Participants	22 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D227, Gr1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D292, Gr0	9 Participants	5 Participants	8 Participants	8 Participants	15 Participants	22 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D204, Gr1	3 Participants	0 Participants	3 Participants	0 Participants	0 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D36, Gr1	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D59, Gr0	26 Participants	25 Participants	24 Participants	26 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D204, Gr0	23 Participants	24 Participants	24 Participants	25 Participants	23 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D227, Gr1	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D292, Gr0	8 Participants	4 Participants	6 Participants	8 Participants	15 Participants	20 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D292, Gr1	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D315, Gr0	20 Participants	21 Participants	21 Participants	20 Participants	20 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D315, Gr1	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, SCR, Gr0	25 Participants	26 Participants	26 Participants	25 Participants	25 Participants	22 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, SCR, Gr1	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D36, Gr0	25 Participants	25 Participants	25 Participants	23 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D36, Gr1	1 Participants	0 Participants	0 Participants	3 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D59, Gr0	26 Participants	25 Participants	25 Participants	26 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D204, Gr0	23 Participants	24 Participants	24 Participants	23 Participants	21 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D204, Gr1	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D227, Gr1	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D315, Gr0	19 Participants	20 Participants	22 Participants	20 Participants	19 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D315, Gr1	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D315, Gr2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D227, Gr0	19 Participants	23 Participants	23 Participants	23 Participants	23 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D227, Gr0	23 Participants	22 Participants	23 Participants	23 Participants	22 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D227, Gr1	4 Participants	0 Participants	1 Participants	1 Participants	0 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, SCR, Gr0	25 Participants	24 Participants	25 Participants	25 Participants	26 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, SCR, Gr1	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D36, Gr0	26 Participants	24 Participants	25 Participants	25 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D36, Gr1	0 Participants	1 Participants	0 Participants	1 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D59, Gr0	26 Participants	24 Participants	24 Participants	24 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D59, Gr1	0 Participants	1 Participants	1 Participants	2 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D204, Gr0	21 Participants	22 Participants	24 Participants	24 Participants	20 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D204, Gr1	2 Participants	2 Participants	0 Participants	1 Participants	3 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D227, Gr0	22 Participants	20 Participants	23 Participants	23 Participants	22 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D227, Gr1	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D227, Gr2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D292, Gr0	9 Participants	4 Participants	7 Participants	8 Participants	10 Participants	22 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D292, Gr1	0 Participants	0 Participants	1 Participants	1 Participants	5 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D292, Gr2	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D315, Gr0	16 Participants	20 Participants	18 Participants	18 Participants	18 Participants	21 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D315, Gr1	3 Participants	1 Participants	4 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Alanine Aminotransferase, D315, Gr2	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, SCR, Gr0	26 Participants	25 Participants	25 Participants	25 Participants	26 Participants	23 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, SCR, Gr1	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D36, Gr0	26 Participants	25 Participants	24 Participants	26 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D36, Gr1	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D59, Gr0	26 Participants	24 Participants	24 Participants	25 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D59, Gr1	0 Participants	1 Participants	1 Participants	1 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D204, Gr0	22 Participants	23 Participants	24 Participants	25 Participants	22 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D204, Gr1	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D227, Gr1	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D227, Gr2	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D292, Gr0	9 Participants	4 Participants	7 Participants	9 Participants	13 Participants	22 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D292, Gr1	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D292, Gr2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D292, Gr3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D315, Gr0	20 Participants	21 Participants	21 Participants	18 Participants	20 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Aspartate Aminotransferase, D315, Gr1	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, SCR, Gr0	26 Participants	26 Participants	26 Participants	25 Participants	26 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, SCR, Gr1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D36, Gr0	25 Participants	25 Participants	25 Participants	26 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D36, Gr1	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D59, Gr0	26 Participants	25 Participants	25 Participants	26 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D204, Gr0	23 Participants	24 Participants	24 Participants	25 Participants	22 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D204, Gr1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D292, Gr1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D292, UNK	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D315, Gr0	20 Participants	21 Participants	21 Participants	20 Participants	20 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Creatinine, D315, Gr1	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, SCR, Gr0	26 Participants	26 Participants	26 Participants	26 Participants	26 Participants	23 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, SCR, Gr1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D36, Gr0	23 Participants	24 Participants	22 Participants	25 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D36, Gr1	3 Participants	1 Participants	3 Participants	1 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D59, Gr0	25 Participants	25 Participants	24 Participants	25 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D59, Gr1	1 Participants	0 Participants	1 Participants	1 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D204, Gr0	20 Participants	24 Participants	21 Participants	25 Participants	23 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D292, Gr0	9 Participants	5 Participants	8 Participants	8 Participants	15 Participants	23 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D292, Gr1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D315, Gr0	16 Participants	21 Participants	19 Participants	18 Participants	21 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D315, Gr1	4 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Hemoglobin, D315, Gr2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, SCR, Gr0	26 Participants	26 Participants	26 Participants	26 Participants	26 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D36, Gr0	26 Participants	25 Participants	25 Participants	26 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D59, Gr0	26 Participants	25 Participants	25 Participants	26 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D204, Gr0	23 Participants	24 Participants	24 Participants	25 Participants	23 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D227, Gr0	23 Participants	23 Participants	24 Participants	24 Participants	23 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D292, Gr0	9 Participants	5 Participants	8 Participants	8 Participants	15 Participants	19 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D292, Gr1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D292, Gr2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D292, Gr3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D315, Gr0	20 Participants	21 Participants	22 Participants	19 Participants	21 Participants	22 Participants
Number of Subjects With Abnormal Laboratory Values Gradings Platelets, D315, Gr1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, SCR, Gr0	25 Participants	25 Participants	26 Participants	26 Participants	26 Participants	24 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, SCR, Gr1	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D36, Gr0	26 Participants	24 Participants	25 Participants	26 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D59, Gr1	0 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Decrease, D227, Gr0	23 Participants	23 Participants	22 Participants	24 Participants	23 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D227, Gr0	22 Participants	23 Participants	23 Participants	24 Participants	23 Participants	—
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D292, Gr0	9 Participants	5 Participants	8 Participants	9 Participants	15 Participants	23 Participants
Number of Subjects With Abnormal Laboratory Values Gradings WBC Increase, D315, Gr3	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From day of challenge (Day 287) to the end of the challenge phase (Day 315)

Population: The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine

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	AduFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 Participants Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 Participants Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
Number of Subjects With Any, Fatal or Related SAE, After Challenge	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

AduFx Group

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

2PedFx Group

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

PedFx Group

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Adu2Fx Group

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Adu1Fx Group

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AduFx Group n=26 participants at risk Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and Month 1 and 1/5th of RTS,S/AS01B full dose at Month 7, and underwent sporozoite challenge.	2PedFx Group n=26 participants at risk Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E double dose at Month 0 and Month 1, and 1/5th of double dose RTS,S/AS01E at Month 7, and underwent sporozoite challenge.	PedFx Group n=26 participants at risk Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01E full dose at Month 0 and Month 1, and 1/5th of RTS,S/AS01E full dose at Month 7, and underwent sporozoite challenge.	Adu2Fx Group n=26 participants at risk Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose at Month 1 and Month 7, and underwent sporozoite challenge.	Adu1Fx Group n=26 participants at risk Healthy subjects, between, and including, 18 and 55 years of age, who received RTS,S/AS01B full dose at Month 0 and 1/5th of RTS,S/AS01B full dose administered at Month 7, and underwent sporozoite challenge.	Control Group n=24 participants at risk Healthy subjects, between, and including, 18 and 55 years of age, who did not receive any immunization but underwent sporozoite challenge
General disorders Asthenia	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Chest pain	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Chills	15.4% 4/26 • Number of events 7 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	11.5% 3/26 • Number of events 4 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	19.2% 5/26 • Number of events 6 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	19.2% 5/26 • Number of events 7 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Fatigue	61.5% 16/26 • Number of events 28 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	76.9% 20/26 • Number of events 33 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	57.7% 15/26 • Number of events 31 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	50.0% 13/26 • Number of events 29 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	53.8% 14/26 • Number of events 20 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Feeling hot	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Injection site erythema	53.8% 14/26 • Number of events 23 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	69.2% 18/26 • Number of events 31 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	46.2% 12/26 • Number of events 19 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	57.7% 15/26 • Number of events 23 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	46.2% 12/26 • Number of events 15 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Injection site pain	88.5% 23/26 • Number of events 54 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	88.5% 23/26 • Number of events 49 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	88.5% 23/26 • Number of events 55 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	84.6% 22/26 • Number of events 50 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	76.9% 20/26 • Number of events 34 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Injection site swelling	34.6% 9/26 • Number of events 13 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	57.7% 15/26 • Number of events 26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	34.6% 9/26 • Number of events 14 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	34.6% 9/26 • Number of events 10 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	30.8% 8/26 • Number of events 8 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Injection site warmth	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Malaise	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Pain	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
General disorders Pyrexia	30.8% 8/26 • Number of events 10 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	46.2% 12/26 • Number of events 15 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	15.4% 4/26 • Number of events 5 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	19.2% 5/26 • Number of events 6 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	11.5% 3/26 • Number of events 3 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Nervous system disorders Dizziness	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Nervous system disorders Headache	76.9% 20/26 • Number of events 35 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	76.9% 20/26 • Number of events 35 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	69.2% 18/26 • Number of events 28 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	61.5% 16/26 • Number of events 28 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	46.2% 12/26 • Number of events 19 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Nervous system disorders Hypoaesthesia	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Nervous system disorders Loss of consciousness	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Nervous system disorders Paraesthesia	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Nervous system disorders Presyncope	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Gastrointestinal disorders Abdominal pain	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Gastrointestinal disorders Dental caries	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Gastrointestinal disorders Dry mouth	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Gastrointestinal disorders Gastrointestinal disorder	34.6% 9/26 • Number of events 12 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	42.3% 11/26 • Number of events 16 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	34.6% 9/26 • Number of events 18 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	23.1% 6/26 • Number of events 7 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	30.8% 8/26 • Number of events 11 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Gastrointestinal disorders Gingival pain	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Gastrointestinal disorders Haematochezia	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Gastrointestinal disorders Sensitivity of teeth	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Gastrointestinal disorders Toothache	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 3 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Costochondritis	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Myalgia	7.7% 2/26 • Number of events 3 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 4 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 3 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Musculoskeletal and connective tissue disorders Neck pain	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Infections and infestations Bronchitis	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Infections and infestations Eye infection	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Infections and infestations Eyelid infection	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Infections and infestations Oral herpes	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Infections and infestations Pharyngitis streptococcal	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Infections and infestations Pyelonephritis	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Infections and infestations Upper respiratory tract infection	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	11.5% 3/26 • Number of events 3 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	11.5% 3/26 • Number of events 3 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	26.9% 7/26 • Number of events 8 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Infections and infestations Viral upper respiratory tract infection	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Skin and subcutaneous tissue disorders Acne	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Skin and subcutaneous tissue disorders Erythema	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Skin and subcutaneous tissue disorders Night sweats	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Skin and subcutaneous tissue disorders Rash	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Skin and subcutaneous tissue disorders Sensitive skin	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 3 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Injury, poisoning and procedural complications Hypobarism	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Injury, poisoning and procedural complications Muscle strain	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Injury, poisoning and procedural complications Procedural pain	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Respiratory, thoracic and mediastinal disorders Cough	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Psychiatric disorders Abnormal dreams	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Psychiatric disorders Depression	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Psychiatric disorders Insomnia	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Psychiatric disorders Sleep disorder	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Blood and lymphatic system disorders Lymphadenopathy	3.8% 1/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Metabolism and nutrition disorders Decreased appetite	3.8% 1/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	7.7% 2/26 • Number of events 2 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Eye disorders Eye irritation	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Eye disorders Eye pain	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).
Investigations White blood cell count increased	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	3.8% 1/26 • Number of events 1 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/26 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).	0.00% 0/24 • Solicited adverse events were reported during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 377).

Additional Information

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• 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.
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