Trial Outcomes & Findings for Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects. (NCT NCT02690181)

NCT ID: NCT02690181

Last Updated: 2024-04-04

Results Overview

Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: At Day 61
• Results posted on: 2024-04-04

Participant Flow

Subjects were recruited from 1 site in Belgium.

All enrolled subjects completed the study.

Participant milestones

Measure	GBS NoAdj/GBS NoAdj Group Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Overall Study STARTED	14	14	15	10	6	21
Overall Study COMPLETED	14	14	15	10	6	21
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.

Baseline characteristics by cohort

Measure	GBS NoAdj/GBS NoAdj Group n=14 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=21 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Total n=80 Participants Total of all reporting groups
Age, Continuous	32.4 Years STANDARD_DEVIATION 6.91 • n=5 Participants	31.6 Years STANDARD_DEVIATION 6.06 • n=7 Participants	28.9 Years STANDARD_DEVIATION 4.68 • n=5 Participants	29.7 Years STANDARD_DEVIATION 6.22 • n=4 Participants	28.3 Years STANDARD_DEVIATION 5.39 • n=21 Participants	29.2 Years STANDARD_DEVIATION 6.96 • n=8 Participants	30.1 Years STANDARD_DEVIATION 6.19 • n=8 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	10 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=8 Participants	80 Participants n=8 Participants
Sex: Female, Male Male	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	0 Participants n=8 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	10 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=8 Participants	80 Participants n=8 Participants

PRIMARY outcome

Timeframe: At Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA).

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=13 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=5 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 ≥ 5 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	93 Percentage of subjects Interval 68.1 to 99.83	90 Percentage of subjects Interval 55.5 to 99.75	60 Percentage of subjects Interval 14.7 to 94.7	60 Percentage of subjects Interval 36.1 to 80.9
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 ≥ 8 µg/mL	92 Percentage of subjects Interval 64.0 to 99.81	100 Percentage of subjects Interval 76.8 to 100.0	93 Percentage of subjects Interval 68.1 to 99.83	90 Percentage of subjects Interval 55.5 to 99.75	60 Percentage of subjects Interval 14.7 to 94.7	60 Percentage of subjects Interval 36.1 to 80.9
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 ≥ 0.1 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 47.8 to 100.0	100 Percentage of subjects Interval 83.2 to 100.0
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 ≥ 0.2 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 47.8 to 100.0	95 Percentage of subjects Interval 75.1 to 99.87
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 ≥ 0.5 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 47.8 to 100.0	90 Percentage of subjects Interval 68.3 to 98.8
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 ≥ 1 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	80 Percentage of subjects Interval 28.4 to 99.5	85 Percentage of subjects Interval 62.1 to 96.8
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 ≥ 2 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	60 Percentage of subjects Interval 14.7 to 94.7	65 Percentage of subjects Interval 40.8 to 84.6
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 ≥ 3 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	93 Percentage of subjects Interval 68.1 to 99.83	90 Percentage of subjects Interval 55.5 to 99.75	60 Percentage of subjects Interval 14.7 to 94.7	60 Percentage of subjects Interval 36.1 to 80.9

PRIMARY outcome

Timeframe: At Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.in this study.

Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=13 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=5 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 ≥ 0.1 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 47.8 to 100.0	85 Percentage of subjects Interval 62.1 to 96.8
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 ≥ 0.2 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 47.8 to 100.0	80 Percentage of subjects Interval 56.3 to 94.3
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 ≥ 0.5 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	80 Percentage of subjects Interval 28.4 to 99.5	70 Percentage of subjects Interval 45.7 to 88.1
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 ≥ 1 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	60 Percentage of subjects Interval 14.7 to 94.7	65 Percentage of subjects Interval 40.8 to 84.6
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 ≥ 2 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	60 Percentage of subjects Interval 14.7 to 94.7	50 Percentage of subjects Interval 27.2 to 72.8
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 ≥ 3 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	93 Percentage of subjects Interval 66.1 to 99.82	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	60 Percentage of subjects Interval 14.7 to 94.7	50 Percentage of subjects Interval 27.2 to 72.8
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 ≥ 5 μg/mL	85 Percentage of subjects Interval 54.6 to 98.1	93 Percentage of subjects Interval 66.1 to 99.82	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	60 Percentage of subjects Interval 14.7 to 94.7	45 Percentage of subjects Interval 23.1 to 68.5
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 ≥ 8 μg/mL	85 Percentage of subjects Interval 54.6 to 98.1	93 Percentage of subjects Interval 66.1 to 99.82	93 Percentage of subjects Interval 68.1 to 99.83	100 Percentage of subjects Interval 69.2 to 100.0	20 Percentage of subjects Interval 0.5 to 71.6	40 Percentage of subjects Interval 19.1 to 63.9

PRIMARY outcome

Timeframe: At Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=13 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=13 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=5 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 ≥ 0.1 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 47.8 to 100.0	100 Percentage of subjects Interval 83.2 to 100.0
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 ≥ 0.2 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 47.8 to 100.0	80 Percentage of subjects Interval 56.3 to 94.3
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 ≥ 0.5 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	80 Percentage of subjects Interval 28.4 to 99.5	80 Percentage of subjects Interval 56.3 to 94.3
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 ≥ 1 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	40 Percentage of subjects Interval 5.3 to 85.3	75 Percentage of subjects Interval 50.9 to 91.3
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 ≥ 2 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	40 Percentage of subjects Interval 5.3 to 85.3	65 Percentage of subjects Interval 40.8 to 84.6
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 ≥ 3 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	40 Percentage of subjects Interval 5.3 to 85.3	65 Percentage of subjects Interval 40.8 to 84.6
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 ≥ 5 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	40 Percentage of subjects Interval 5.3 to 85.3	50 Percentage of subjects Interval 27.2 to 72.8
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 ≥ 8 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	92 Percentage of subjects Interval 64.0 to 99.81	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	40 Percentage of subjects Interval 5.3 to 85.3	50 Percentage of subjects Interval 27.2 to 72.8

PRIMARY outcome

Timeframe: Day 1 to Day 7

Population: All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any solicited adverse event data and/or indicators of solicited adverse events (e.g., use of analgesics/antipyretics).

Threshold for Erythema, Swelling and Induration: None (0 mm), Any (>= 1 mm).

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=14 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=5 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=21 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Fatigue	3 Participants	10 Participants	4 Participants	4 Participants	1 Participants	2 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Any Local	11 Participants	12 Participants	10 Participants	6 Participants	3 Participants	11 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Pain	10 Participants	9 Participants	9 Participants	6 Participants	3 Participants	11 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Erythema	1 Participants	4 Participants	2 Participants	1 Participants	1 Participants	3 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Swelling	0 Participants	2 Participants	4 Participants	1 Participants	1 Participants	0 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Warmth	1 Participants	4 Participants	4 Participants	2 Participants	2 Participants	2 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Induration	2 Participants	2 Participants	5 Participants	2 Participants	1 Participants	0 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Ecchymosis	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Any Systemic	5 Participants	11 Participants	7 Participants	5 Participants	2 Participants	5 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Chills	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Nausea	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Malaise	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants	1 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Generalized Myalgia	2 Participants	2 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Generalized Arthralgia	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Headache	4 Participants	4 Participants	5 Participants	2 Participants	2 Participants	4 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Body Rash	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) Fever (≥ 38°C)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 31

Population: All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any unsolicited adverse event data.

The number of subjects with any unsolicited AEs from the day of vaccination in study V98_06E1 to Day 31. An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Possibly Related AE definition: the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes. Probably Related AE definition: exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=14 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=21 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Number of Subjects With Any Unsolicited Adverse Events (AEs) Any AE	4 Participants	5 Participants	4 Participants	4 Participants	4 Participants	9 Participants
Number of Subjects With Any Unsolicited Adverse Events (AEs) At least possibly or probably related AEs	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 181

Population: All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any unsolicited adverse event data.

An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. "Medically attended adverse event" is defined as an adverse event that leads to a visit to a healthcare provider and "AEs leading to withdrawal" are defined as adverse events leading to study or vaccine withdrawal.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=14 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=21 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal Medically attended AEs	5 Participants	5 Participants	7 Participants	0 Participants	2 Participants	5 Participants
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal AEs leading to withdrawal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Day 31

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 31 post-vaccination, as measured by ELISA.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=13 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 ≥ 0.1 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 54.1 to 100.0	100 Percentage of subjects Interval 83.2 to 100.0
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 ≥ 0.2 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 54.1 to 100.0	85 Percentage of subjects Interval 62.1 to 96.8
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 ≥ 0.5 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 54.1 to 100.0	80 Percentage of subjects Interval 56.3 to 94.3
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 ≥ 1 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	83 Percentage of subjects Interval 35.9 to 99.58	75 Percentage of subjects Interval 50.9 to 91.3
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 ≥ 2 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	67 Percentage of subjects Interval 22.3 to 95.7	60 Percentage of subjects Interval 36.1 to 80.9
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 ≥ 3 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	67 Percentage of subjects Interval 22.3 to 95.7	60 Percentage of subjects Interval 36.1 to 80.9
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 ≥ 5 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	93 Percentage of subjects Interval 68.1 to 99.83	90 Percentage of subjects Interval 55.5 to 99.75	67 Percentage of subjects Interval 22.3 to 95.7	60 Percentage of subjects Interval 36.1 to 80.9
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 ≥ 8 µg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	93 Percentage of subjects Interval 68.1 to 99.83	90 Percentage of subjects Interval 55.5 to 99.75	67 Percentage of subjects Interval 22.3 to 95.7	60 Percentage of subjects Interval 36.1 to 80.9

SECONDARY outcome

Timeframe: At Day 31

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=13 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 ≥ 0.1 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 54.1 to 100.0	75 Percentage of subjects Interval 50.9 to 91.3
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 ≥ 0.2 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 54.1 to 100.0	70 Percentage of subjects Interval 45.7 to 88.1
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 ≥ 0.5 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	83 Percentage of subjects Interval 35.9 to 99.58	60 Percentage of subjects Interval 36.1 to 80.9
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 ≥ 1 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	83 Percentage of subjects Interval 35.9 to 99.58	45 Percentage of subjects Interval 23.1 to 68.5
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 ≥ 2 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 76.8 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	50 Percentage of subjects Interval 11.8 to 88.2	45 Percentage of subjects Interval 23.1 to 68.5
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 ≥ 3 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	93 Percentage of subjects Interval 66.1 to 99.82	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	50 Percentage of subjects Interval 11.8 to 88.2	45 Percentage of subjects Interval 23.1 to 68.5
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 ≥ 5 μg/mL	92 Percentage of subjects Interval 64.0 to 99.81	93 Percentage of subjects Interval 66.1 to 99.82	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	50 Percentage of subjects Interval 11.8 to 88.2	45 Percentage of subjects Interval 23.1 to 68.5
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 ≥ 8 μg/mL	85 Percentage of subjects Interval 54.6 to 98.1	93 Percentage of subjects Interval 66.1 to 99.82	93 Percentage of subjects Interval 68.1 to 99.83	100 Percentage of subjects Interval 69.2 to 100.0	50 Percentage of subjects Interval 11.8 to 88.2	45 Percentage of subjects Interval 23.1 to 68.5

SECONDARY outcome

Timeframe: At Day 31

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=13 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=13 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 ≥ 0.1 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	100 Percentage of subjects Interval 54.1 to 100.0	100 Percentage of subjects Interval 83.2 to 100.0
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 ≥ 0.2 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	67 Percentage of subjects Interval 22.3 to 95.7	75 Percentage of subjects Interval 50.9 to 91.3
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 ≥ 0.5 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	67 Percentage of subjects Interval 22.3 to 95.7	70 Percentage of subjects Interval 45.7 to 88.1
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 ≥ 1 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	50 Percentage of subjects Interval 11.8 to 88.2	65 Percentage of subjects Interval 40.8 to 84.6
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 ≥ 2 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	50 Percentage of subjects Interval 11.8 to 88.2	60 Percentage of subjects Interval 36.1 to 80.9
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 ≥ 3 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	33 Percentage of subjects Interval 4.3 to 77.7	55 Percentage of subjects Interval 31.5 to 76.9
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 ≥ 5 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 75.3 to 100.0	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	33 Percentage of subjects Interval 4.3 to 77.7	55 Percentage of subjects Interval 31.5 to 76.9
Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 ≥ 8 μg/mL	100 Percentage of subjects Interval 75.3 to 100.0	92 Percentage of subjects Interval 64.0 to 99.81	100 Percentage of subjects Interval 78.2 to 100.0	100 Percentage of subjects Interval 69.2 to 100.0	33 Percentage of subjects Interval 4.3 to 77.7	50 Percentage of subjects Interval 27.2 to 72.8

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61.

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in All Subjects were estimated for at Day 1, Day 31 and Day 61.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=14 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia Serotype Ia - Day 1 (V98_06E1)	9.32 µg/mL Interval 3.03 to 29.0	5.50 µg/mL Interval 1.79 to 17.0	3.44 µg/mL Interval 1.16 to 10.0	2.18 µg/mL Interval 0.58 to 8.24	1.05 µg/mL Interval 0.19 to 5.86	0.32 µg/mL Interval 0.13 to 0.83
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia Serotype Ia - Day 31	61.13 µg/mL Interval 23.0 to 165.0	81.61 µg/mL Interval 31.0 to 213.0	64.19 µg/mL Interval 25.0 to 162.0	57.54 µg/mL Interval 19.0 to 179.0	19.25 µg/mL Interval 4.46 to 83.0	10.06 µg/mL Interval 4.52 to 22.0
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia Serotype Ia - Day 61	51.53 µg/mL Interval 21.0 to 129.0	65.30 µg/mL Interval 27.0 to 158.0	44.69 µg/mL Interval 19.0 to 105.0	50.67 µg/mL Interval 18.0 to 145.0	21.36 µg/mL Interval 4.85 to 94.0	10.02 µg/mL Interval 4.77 to 21.0

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean Antibody Concentrations of GBS Serotype Ib in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=14 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean Antibody Concentrations of GBS Serotype Ib Day 1	0.19 µg/mL Interval 0.093 to 0.41	0.15 µg/mL Interval 0.073 to 0.32	0.10 µg/mL Interval 0.049 to 0.2	0.16 µg/mL Interval 0.068 to 0.39	0.14 µg/mL Interval 0.035 to 0.55	0.17 µg/mL Interval 0.093 to 0.32
Geometric Mean Antibody Concentrations of GBS Serotype Ib Day 31	80.62 µg/mL Interval 28.0 to 232.0	74.96 µg/mL Interval 27.0 to 207.0	89.59 µg/mL Interval 33.0 to 241.0	85.90 µg/mL Interval 26.0 to 286.0	6.61 µg/mL Interval 0.99 to 44.0	3.55 µg/mL Interval 1.52 to 8.34
Geometric Mean Antibody Concentrations of GBS Serotype Ib Day 61	56.32 µg/mL Interval 22.0 to 145.0	57.82 µg/mL Interval 23.0 to 143.0	59.13 µg/mL Interval 24.0 to 143.0	65.53 µg/mL Interval 22.0 to 192.0	5.51 µg/mL Interval 1.01 to 30.0	4.47 µg/mL Interval 2.09 to 9.58

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean Antibody Concentrations of GBS Serotype III in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=14 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=13 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=20 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean Antibody Concentrations of GBS Serotype III Day 1	0.41 µg/mL Interval 0.2 to 0.82	0.17 µg/mL Interval 0.085 to 0.36	0.25 µg/mL Interval 0.13 to 0.49	0.17 µg/mL Interval 0.076 to 0.39	0.15 µg/mL Interval 0.04 to 0.54	0.31 µg/mL Interval 0.17 to 0.55
Geometric Mean Antibody Concentrations of GBS Serotype III Day 31	111.30 µg/mL Interval 42.0 to 294.0	104.55 µg/mL Interval 40.0 to 277.0	109.23 µg/mL Interval 44.0 to 269.0	216.39 µg/mL Interval 71.0 to 655.0	2.66 µg/mL Interval 0.46 to 15.0	5.33 µg/mL Interval 2.43 to 12.0
Geometric Mean Antibody Concentrations of GBS Serotype III Day 61	91.30 µg/mL Interval 39.0 to 214.0	80.94 µg/mL Interval 34.0 to 190.0	81.71 µg/mL Interval 37.0 to 180.0	200.78 µg/mL Interval 76.0 to 531.0	2.67 µg/mL Interval 0.57 to 12.0	5.82 µg/mL Interval 2.92 to 12.0

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=7 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=10 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=9 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=7 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=4 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=15 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) Serotype Ia - Day 1 (V98_06E1)	1.36 µg/mL Interval 0.43 to 4.27	2.59 µg/mL Interval 0.99 to 6.75	0.81 µg/mL Interval 0.3 to 2.24	1.12 µg/mL Interval 0.36 to 3.52	0.45 µg/mL Interval 0.099 to 2.05	0.16 µg/mL Interval 0.074 to 0.36
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) Serotype Ia - Day 31	32.25 µg/mL Interval 8.59 to 121.0	62.54 µg/mL Interval 21.0 to 189.0	35.47 µg/mL Interval 11.0 to 114.0	46.11 µg/mL Interval 12.0 to 173.0	6.34 µg/mL Interval 1.1 to 36.0	3.98 µg/mL Interval 1.61 to 9.84
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) Serotype Ia - Day 61	26.33 µg/mL Interval 8.12 to 85.0	49.01 µg/mL Interval 18.0 to 131.0	24.89 µg/mL Interval 8.82 to 70.0	39.56 µg/mL Interval 12.0 to 128.0	5.79 µg/mL Interval 0.96 to 35.0	4.25 µg/mL Interval 1.9 to 9.48

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=10 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=9 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=14 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=8 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=3 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=15 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ Day 1	0.078 µg/mL Interval 0.078 to 0.078	0.078 µg/mL Interval 0.078 to 0.078	0.078 µg/mL Interval 0.078 to 0.078	0.078 µg/mL Interval 0.078 to 0.078	0.078 µg/mL Interval 0.078 to 0.078	0.078 µg/mL Interval 0.078 to 0.078
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ Day 31	60.78 µg/mL Interval 20.0 to 182.0	69.05 µg/mL Interval 22.0 to 220.0	53.01 µg/mL Interval 21.0 to 134.0	65.50 µg/mL Interval 19.0 to 224.0	1.47 µg/mL Interval 0.2 to 11.0	0.79 µg/mL Interval 0.32 to 1.95
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ Day 61	40.59 µg/mL Interval 15.0 to 111.0	47.71 µg/mL Interval 16.0 to 138.0	34.12 µg/mL Interval 15.0 to 80.0	47.58 µg/mL Interval 15.0 to 147.0	1.32 µg/mL Interval 0.21 to 8.37	1.19 µg/mL Interval 0.52 to 2.71

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=10 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=12 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=11 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=9 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=4 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=15 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ Day 1	0.15 µg/mL Interval 0.15 to 0.15	0.15 µg/mL Interval 0.15 to 0.15	0.15 µg/mL Interval 0.15 to 0.15	0.15 µg/mL Interval 0.15 to 0.15	0.15 µg/mL Interval 0.15 to 0.15	0.15 µg/mL Interval 0.15 to 0.15
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ Day 31	109.31 µg/mL Interval 40.0 to 301.0	77.97 µg/mL Interval 31.0 to 197.0	126.89 µg/mL Interval 48.0 to 333.0	188.63 µg/mL Interval 65.0 to 549.0	1.90 µg/mL Interval 0.38 to 9.44	2.12 µg/mL Interval 0.93 to 4.84
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ Day 61	83.19 µg/mL Interval 33.0 to 208.0	60.01 µg/mL Interval 26.0 to 138.0	87.40 µg/mL Interval 37.0 to 209.0	169.45 µg/mL Interval 65.0 to 444.0	1.92 µg/mL Interval 0.45 to 8.16	2.52 µg/mL Interval 1.2 to 5.32

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=7 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=3 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=6 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=2 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=2 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=5 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Serotype Ia - Day 31	128.91 µg/mL Interval 71.0 to 234.0	196.32 µg/mL Interval 85.0 to 456.0	156.26 µg/mL Interval 86.0 to 284.0	85.63 µg/mL Interval 31.0 to 240.0	177.38 µg/mL Interval 63.0 to 498.0	161.99 µg/mL Interval 84.0 to 311.0
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Serotype Ia - Day 1 (V98_06E1)	64.06 µg/mL Interval 23.0 to 178.0	98.43 µg/mL Interval 21.0 to 469.0	29.83 µg/mL Interval 9.89 to 90.0	39.57 µg/mL Interval 5.84 to 268.0	5.76 µg/mL Interval 0.85 to 39.0	2.54 µg/mL Interval 0.76 to 8.5
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Serotype Ia - Day 61	112.78 µg/mL Interval 57.0 to 222.0	197.67 µg/mL Interval 76.0 to 515.0	107.57 µg/mL Interval 55.0 to 212.0	93.02 µg/mL Interval 29.0 to 300.0	151.27 µg/mL Interval 47.0 to 488.0	131.48 µg/mL Interval 63.0 to 276.0

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=4 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=5 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=1 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=2 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=1 Participants Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=5 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Day 1	1.96 µg/mL Interval 0.56 to 6.85	0.52 µg/mL Interval 0.17 to 1.6	3.42 µg/mL Interval 0.28 to 42.0	3.12 µg/mL Interval 0.53 to 18.0	0.82 µg/mL Interval 0.067 to 10.0	1.92 µg/mL Interval 0.63 to 5.89
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Day 31	287.34 µg/mL Interval 90.0 to 917.0	121.26 µg/mL Interval 44.0 to 333.0	373.02 µg/mL Interval 48.0 to 2877.0	338.80 µg/mL Interval 78.0 to 1469.0	557.46 µg/mL Interval 75.0 to 4142.0	557.03 µg/mL Interval 225.0 to 1379.0
Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Day 61	228.26 µg/mL Interval 72.0 to 726.0	118.94 µg/mL Interval 43.0 to 326.0	367.26 µg/mL Interval 48.0 to 2818.0	300.10 µg/mL Interval 69.0 to 1296.0	378.70 µg/mL Interval 51.0 to 2800.0	403.16 µg/mL Interval 163.0 to 996.0

SECONDARY outcome

Timeframe: At Day 1, Day 31 and Day 61

Population: All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.

The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Outcome measures

Measure	GBS NoAdj/GBS NoAdj Group n=4 Participants Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=1 Participants Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=4 Participants Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=1 Participants Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=5 Participants Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Day 1	5.33 µg/mL Interval 0.76 to 37.0	1.41 µg/mL Interval 0.029 to 68.0	1.07 µg/mL Interval 0.15 to 7.46	0.74 µg/mL Interval 0.015 to 36.0	—	2.79 µg/mL Interval 0.49 to 16.0
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Day 31	171.67 µg/mL Interval 13.0 to 2214.0	270.01 µg/mL Interval 3.46 to 21064.0	120.00 µg/mL Interval 13.0 to 1113.0	149.93 µg/mL Interval 1.81 to 12454.0	—	136.68 µg/mL Interval 19.0 to 979.0
Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ Day 61	186.63 µg/mL Interval 24.0 to 1439.0	231.17 µg/mL Interval 7.12 to 7509.0	107.21 µg/mL Interval 18.0 to 635.0	180.29 µg/mL Interval 5.28 to 6158.0	—	116.43 µg/mL Interval 24.0 to 561.0

SECONDARY outcome

Timeframe: At Day 1 (V98_06 or V98_06E1) and Day 61

Population: Anti-diphtheria antibody testing was not performed in this study because no diphtheria vaccine was administered in the study and also because data from other CRM-based vaccines demonstrate that administration has not resulted in a decline in anti-diphtheria antibody concentrations.

Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations (95%CI) in All Subjects at Day 1 Pre-vaccination in the V98_06 study or V98_06E1 for the Naive Group and at Day 61 Post-vaccination in Study V98_06E1. Anti-diphtheria antibody testing was not performed in this study because no diphtheria vaccine was administered in the study and also because data from other Cross Reactive Material(CRM)-based vaccines demonstrate that administration has not resulted in a decline in anti-diphtheria antibody concentrations.

Outcome measures

Outcome data not reported

Adverse Events

GBS NoAdj/GBS NoAdj Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

GBS Alum/GBS NoAdj Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

GBS MF59 Half/GBS NoAdj Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

GBS MF59 Full/GBS NoAdj Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo/GBS NoAdj Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Naive/GBS NoAdj Group

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GBS NoAdj/GBS NoAdj Group n=14 participants at risk Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS Alum/GBS NoAdj Group n=14 participants at risk Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Half/GBS NoAdj Group n=15 participants at risk Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	GBS MF59 Full/GBS NoAdj Group n=10 participants at risk Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Placebo/GBS NoAdj Group n=6 participants at risk Subjects who had received placebo in parent study V98\_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).	Naive/GBS NoAdj Group n=21 participants at risk Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98\_06E1 (205421 - NCT02690181).
Eye disorders Conjunctival irritation	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Ear and labyrinth disorders Ear disorder	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Eye disorders Eye irritation	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Gastrointestinal disorders Diarrhoea	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Gastrointestinal disorders Gastric disorder	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Gastrointestinal disorders Nausea	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	21.4% 3/14 • Number of events 4 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	13.3% 2/15 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Gastrointestinal disorders Tongue ulceration	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Chills	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	10.0% 1/10 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Fatigue	21.4% 3/14 • Number of events 11 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	71.4% 10/14 • Number of events 13 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	26.7% 4/15 • Number of events 9 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	40.0% 4/10 • Number of events 6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	9.5% 2/21 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Feeling hot	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	10.0% 1/10 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Influenza like illness	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Injection site erythema	7.1% 1/14 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	28.6% 4/14 • Number of events 6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	13.3% 2/15 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	10.0% 1/10 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 8 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	14.3% 3/21 • Number of events 5 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Injection site haemorrhage	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Injection site induration	14.3% 2/14 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	14.3% 2/14 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	33.3% 5/15 • Number of events 10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	20.0% 2/10 • Number of events 6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 5 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Injection site pain	71.4% 10/14 • Number of events 20 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	64.3% 9/14 • Number of events 15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	60.0% 9/15 • Number of events 19 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	60.0% 6/10 • Number of events 10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	50.0% 3/6 • Number of events 12 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	52.4% 11/21 • Number of events 23 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Injection site swelling	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	14.3% 2/14 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	26.7% 4/15 • Number of events 6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	10.0% 1/10 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 5 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Injection site warmth	7.1% 1/14 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	28.6% 4/14 • Number of events 5 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	26.7% 4/15 • Number of events 7 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	20.0% 2/10 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	33.3% 2/6 • Number of events 8 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	9.5% 2/21 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Malaise	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	14.3% 2/14 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	13.3% 2/15 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	20.0% 2/10 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Immune system disorders Allergy to arthropod bite	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Chlamydial infection	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Gastroenteritis	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Sinusitis	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Sinusitis bacterial	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Tonsillitis	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Tooth infection	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Upper respiratory tract infection	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	14.3% 3/21 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Injury, poisoning and procedural complications Laceration	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	9.5% 2/21 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	13.3% 2/15 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	6.7% 1/15 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	9.5% 2/21 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	10.0% 1/10 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 2/14 • Number of events 4 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	14.3% 2/14 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	20.0% 3/15 • Number of events 4 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	10.0% 1/10 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	10.0% 1/10 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Nervous system disorders Headache	35.7% 5/14 • Number of events 12 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	42.9% 6/14 • Number of events 12 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	33.3% 5/15 • Number of events 9 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	30.0% 3/10 • Number of events 3 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	33.3% 2/6 • Number of events 4 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	19.0% 4/21 • Number of events 6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	16.7% 1/6 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	10.0% 1/10 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	9.5% 2/21 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Skin and subcutaneous tissue disorders Rash	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Vascular disorders Hot flush	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	7.1% 1/14 • Number of events 2 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/21 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Ear and labyrinth disorders Tinnitus	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
General disorders Hangover	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Gingivitis	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Infections and infestations Rhinitis	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/14 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/15 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/10 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	0.00% 0/6 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.	4.8% 1/21 • Number of events 1 • Solicited AEs were collected until 7 days after vaccination. Unsolicited AEs were collected from Day 1 to Day 181. SAEs were collected from Day 1 to Day 181.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER