Trial Outcomes & Findings for Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women (NCT NCT02046148)

Results Overview

To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

At Birth, Day 42 and Day 90

Results posted on

2020-12-29

Participant Flow

Subjects were enrolled in United States.

Participant milestones

Participant milestones
Measure	GBS Group Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Overall Study STARTED	49	26
Overall Study COMPLETED	48	23
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	GBS Group Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GBS Group n=49 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=26 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Total n=75 Participants Total of all reporting groups
Age, Continuous	29.4 Years STANDARD_DEVIATION 4.2 • n=5 Participants	29.4 Years STANDARD_DEVIATION 5.1 • n=7 Participants	29.4 Years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	26 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Birth, Day 42 and Day 90

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	GBS Group n=44 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=23 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-Ia Birth	6.98 µg/mL Interval 3.09 to 16.0	0.24 µg/mL Interval 0.085 to 0.69
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-Ia Day 42	6.18 µg/mL Interval 2.6 to 15.0	0.39 µg/mL Interval 0.12 to 1.23
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-Ia Day 90	2.74 µg/mL Interval 1.2 to 6.28	0.33 µg/mL Interval 0.11 to 0.98

PRIMARY outcome

Timeframe: At Birth, Day 42 and Day 90

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. 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

Outcome measures
Measure	GBS Group n=41 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=23 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-Ib Birth	4.65 µg/mL Interval 2.07 to 10.0	0.6 µg/mL Interval 0.22 to 1.68
Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-Ib Day 42	3.02 µg/mL Interval 1.29 to 7.07	0.63 µg/mL Interval 0.21 to 1.94
Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-Ib Day 90	1.81 µg/mL Interval 0.83 to 3.94	0.52 µg/mL Interval 0.19 to 1.45

PRIMARY outcome

Timeframe: At Birth, Day 42 and Day 90

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. 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

Outcome measures
Measure	GBS Group n=40 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=22 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-III Birth	7.97 µg/mL Interval 3.18 to 20.0	0.21 µg/mL Interval 0.064 to 0.67
Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-III Day 42	2.64 µg/mL Interval 1.06 to 6.56	0.25 µg/mL Interval 0.075 to 0.84
Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age Anti-III Day 90	2.01 µg/mL Interval 0.75 to 5.36	0.22 µg/mL Interval 0.06 to 0.78

PRIMARY outcome

Timeframe: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate serotype-specific (Ia) GBS serum IgG antibody levels (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	GBS Group n=48 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=26 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Day 42 postpartum	13 µg/mL Interval 6.91 to 24.0	0.64 µg/mL Interval 0.3 to 1.4
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Day 90 postpartum	8.38 µg/mL Interval 4.42 to 16.0	0.58 µg/mL Interval 0.25 to 1.35
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Day 1 pre-vaccination	0.49 µg/mL Interval 0.29 to 0.82	0.33 µg/mL Interval 0.18 to 0.62
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Day 31 post-vaccination	8.99 µg/mL Interval 4.7 to 17.0	0.4 µg/mL Interval 0.18 to 0.85
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Delivery	5.37 µg/mL Interval 2.97 to 9.71	0.36 µg/mL Interval 0.18 to 0.71

PRIMARY outcome

Timeframe: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. 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

Outcome measures
Measure	GBS Group n=47 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=26 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Day 31 post-vaccination	7.32 µg/mL Interval 3.48 to 15.0	0.47 µg/mL Interval 0.2 to 1.11
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Day 1 pre-vaccination	0.34 µg/mL Interval 0.24 to 0.48	0.42 µg/mL Interval 0.28 to 0.63
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Delivery	5.59 µg/mL Interval 2.98 to 10.0	0.41 µg/mL Interval 0.2 to 0.85
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Day 42 postpartum	8.9 µg/mL Interval 4.72 to 17.0	0.61 µg/mL Interval 0.27 to 1.38
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Day 90 postpartum	6.15 µg/mL Interval 3.22 to 12.0	0.53 µg/mL Interval 0.22 to 1.29

PRIMARY outcome

Timeframe: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. 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

Outcome measures
Measure	GBS Group n=43 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=25 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Day 42 postpartum	3.74 µg/mL Interval 2.24 to 6.25	0.26 µg/mL Interval 0.13 to 0.5
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Day 90 postpartum	4.04 µg/mL Interval 2.43 to 6.71	0.3 µg/mL Interval 0.15 to 0.62
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Day 1 pre-vaccination	0.31 µg/mL Interval 0.18 to 0.54	0.19 µg/mL Interval 0.1 to 0.34
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Day 31 post-vaccination	3.61 µg/mL Interval 1.51 to 8.61	0.28 µg/mL Interval 0.12 to 0.69
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Delivery	4.4 µg/mL Interval 2.1 to 9.2	0.27 µg/mL Interval 0.13 to 0.56

PRIMARY outcome

Timeframe: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ia) GBS serum IgG antibody concentrations (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	GBS Group n=44 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=25 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Day 31/Day 1	25 Ratio Interval 13.0 to 49.0	1.05 Ratio Interval 0.49 to 2.26
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Delivery/Day 1	16 Ratio Interval 8.85 to 29.0	1.03 Ratio Interval 0.52 to 2.04
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Day 90/Day 1	23 Ratio Interval 12.0 to 43.0	1.5 Ratio Interval 0.64 to 3.52
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ia Day 42/Day 1	32 Ratio Interval 18.0 to 59.0	1.55 Ratio Interval 0.71 to 3.36

PRIMARY outcome

Timeframe: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. 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

Outcome measures
Measure	GBS Group n=41 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=25 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Day 31/Day 1	21 Ratio Interval 10.0 to 44.0	1.39 Ratio Interval 0.59 to 3.26
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Delivery/Day 1	16 Ratio Interval 8.72 to 31.0	1.28 Ratio Interval 0.63 to 2.6
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Day 42/Day 1	28 Ratio Interval 15.0 to 53.0	1.9 Ratio Interval 0.83 to 4.34
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-Ib Day 90/Day 1	20 Ratio Interval 10.0 to 38.0	1.75 Ratio Interval 0.71 to 4.32

PRIMARY outcome

Timeframe: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. 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

Outcome measures
Measure	GBS Group n=37 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=24 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Delivery/Day 1	21 Ratio Interval 9.38 to 45.0	0.98 Ratio Interval 0.45 to 2.13
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Day 90/Day 1	16 Ratio Interval 9.39 to 27.0	0.98 Ratio Interval 0.46 to 2.1
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Day 31/Day 1	16 Ratio Interval 6.44 to 40.0	0.97 Ratio Interval 0.38 to 2.46
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum Anti-III Day 42/Day 1	16 Ratio Interval 9.6 to 28.0	0.99 Ratio Interval 0.49 to 1.98

SECONDARY outcome

Timeframe: At Delivery

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate the relationship of serotype-specific Ia GBS IgG antibody levels (anti-Ia) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	GBS Group n=38 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=22 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Ratio of GBS IgG Antibody Levels - Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery	0.75 Ratio Interval 0.63 to 0.89	0.86 Ratio Interval 0.69 to 1.07

SECONDARY outcome

Timeframe: At Delivery

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate the relationship of serotype-specific Ib GBS IgG antibody levels (anti-Ib) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. 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

Outcome measures
Measure	GBS Group n=34 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=22 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Ratio of GBS IgG Antibody Levels - Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery	0.82 Ratio Interval 0.73 to 0.92	0.95 Ratio Interval 0.82 to 1.09

SECONDARY outcome

Timeframe: At Delivery

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, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.

To evaluate the relationship of serotype-specific III GBS IgG antibody levels (anti-III) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. 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

Outcome measures
Measure	GBS Group n=32 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=21 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Ratio of GBS IgG Antibody Levels - Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery	0.62 Ratio Interval 0.51 to 0.76	0.87 Ratio Interval 0.69 to 1.1

SECONDARY outcome

Timeframe: Up to 30 minutes post-vaccination

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 and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.

Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (\<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.

Outcome measures

SECONDARY outcome

Timeframe: During Study Days 1-3 (from 6 hours through Day 3 post-vaccination)

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 and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.

Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (\<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.

Outcome measures

Outcome measures
Measure	GBS Group n=48 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=26 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Local Swelling	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Local Pain	24 Percentage of Maternal Subjects	8 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Local Warmth	3 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Arthralgia	1 Percentage of Maternal Subjects	2 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Fatigue	13 Percentage of Maternal Subjects	6 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Loss of appetite	4 Percentage of Maternal Subjects	2 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Myalgia	1 Percentage of Maternal Subjects	2 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Nausea	7 Percentage of Maternal Subjects	2 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Rash	1 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Fever (≥ 38°C)	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Chills	0 Percentage of Maternal Subjects	1 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Headache	5 Percentage of Maternal Subjects	3 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Systemic Urticaria	1 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Local Ecchymosis	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Local Erythema	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 Local Induration	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects

SECONDARY outcome

Timeframe: During Study Days 4-7

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 and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.

Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (\<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.

Outcome measures

SECONDARY outcome

Timeframe: During Study Days 1-7 (from 6 hours through Day 7 post-vaccination)

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 and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.

Percentage and frequency of maternal subjects with solicited local and solicited systemic adverse events up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (\<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.

Outcome measures

Outcome measures
Measure	GBS Group n=48 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=26 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Local Pain	24 Percentage of Maternal Subjects	8 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Local Ecchymosis	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Local Erythema	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Local Induration	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Local Swelling	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Local Warmth	3 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Arthralgia	2 Percentage of Maternal Subjects	2 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Chills	1 Percentage of Maternal Subjects	1 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Fatigue	18 Percentage of Maternal Subjects	6 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Headache	6 Percentage of Maternal Subjects	3 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Loss of appetite	6 Percentage of Maternal Subjects	2 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Myalgia	2 Percentage of Maternal Subjects	2 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Nausea	7 Percentage of Maternal Subjects	3 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Rash	1 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Urticaria	1 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 Systemic Fever (≥ 38°C)	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects

SECONDARY outcome

Timeframe: From Study Day 1 through Study 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 and who received a study vaccination and who provided data on unsolicited adverse events.

An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes inter-current illnesses or injuries and exacerbation of pre-existing conditions.

Outcome measures

Outcome measures
Measure	GBS Group n=49 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=26 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Percentage of Maternal Subjects With Any Unsolicited AEs	18 Percentage of Maternal Subjects	6 Percentage of Maternal Subjects

SECONDARY outcome

Timeframe: From Study Day 1 through Study 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 and who received a study vaccination and who provided data on unsolicited adverse events.

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. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.

Outcome measures

Outcome measures
Measure	GBS Group n=49 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=26 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) Any SAE from Day 1 to Day 31	1 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) Any MAE from Day 1 to Day 31	10 Percentage of Maternal Subjects	4 Percentage of Maternal Subjects
Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) Any AE lead. Wthwal Day 1 to Day 31	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects

SECONDARY outcome

Timeframe: From Study Day 32 through Day 180 postpartum

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 and who received a study vaccination and who provided data on unsolicited adverse events.

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. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.

Outcome measures

Outcome measures
Measure	GBS Group n=49 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).	Placebo Group n=26 Participants Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) Any MAE from Day 32 to Day 180	38 Percentage of Maternal Subjects	17 Percentage of Maternal Subjects
Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) Any SAE from Day 32 to Day 180	7 Percentage of Maternal Subjects	4 Percentage of Maternal Subjects
Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) Any AE lead. Wthwal Day 32 to Day 180	0 Percentage of Maternal Subjects	0 Percentage of Maternal Subjects

SECONDARY outcome

Timeframe: From Birth through Day 180 of age

Population: Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.

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. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.