Trial Outcomes & Findings for Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine (NCT NCT02270944)

Last Updated: 2019-12-05

Results Overview

To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. 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

1053 participants

Primary outcome timeframe

At Day 31 after a single vaccination

Results posted on

2019-12-05

Participant Flow

1053 subjects were enrolled at Belgium, US and Czech Republic sites.

Among the 1053 subjects enrolled in the study, 3 subjects were randomized but didn't receive the vaccine. The 3 subjects were excluded and didn't start the study.

Participant milestones

Participant milestones
Measure	Liquid GBS Trivalent Vaccine Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Overall Study STARTED	529	521
Overall Study COMPLETED	518	516
Overall Study NOT COMPLETED	11	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Liquid GBS Trivalent Vaccine Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Overall Study Lost to Follow-up	9	4
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liquid GBS Trivalent Vaccine n=529 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=521 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine	Total n=1050 Participants Total of all reporting groups
Age, Continuous	27.1 Years STANDARD_DEVIATION 6.24 • n=5 Participants	27.4 Years STANDARD_DEVIATION 6.05 • n=7 Participants	27.2 Years STANDARD_DEVIATION 6.15 • n=5 Participants
Sex: Female, Male Female	529 Participants n=5 Participants	521 Participants n=7 Participants	1050 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 Day 31 after a single vaccination

Population: All subjects in the Full Analysis Set immunogenicity population who received the study vaccine, have no major protocol deviation or other reasons to be excluded as defined prior to unblinding \& provided evaluable serum samples both before vaccination and at Day 31 in the protocol required windows.

Outcome measures

Outcome measures
Measure	Liquid GBS Trivalent Vaccine n=521 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=513 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women	6.81 µg/mL Interval 5.54 to 8.37	6.66 µg/mL Interval 5.4 to 8.21

PRIMARY outcome

Timeframe: At Day 31 after a single vaccination

To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. 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	Liquid GBS Trivalent Vaccine n=492 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=489 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women	2.42 µg/mL Interval 1.95 to 3.01	2.44 µg/mL Interval 1.95 to 3.04

PRIMARY outcome

Timeframe: At Day 31 after a single vaccination

To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Geometric mean concentrations (GMCs) were measured and expressed in micrograms per milliliter (μg/mL). As the singleton ELISA was no longer in use at the time of serotype Ib testing, results were obtained using multiplex immunoassay.

Outcome measures

Outcome measures
Measure	Liquid GBS Trivalent Vaccine n=483 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=470 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women	2.94 µg/mL Interval 2.37 to 3.65	3.14 µg/mL Interval 2.53 to 3.9

SECONDARY outcome

Timeframe: From 6 hours through Day 7 post-vaccination

Population: Analyses were evaluated on the Solicited Safety Set (i.e. all subjects in the exposed set with data on post vaccination local or systemic AEs or other signs of reactogenicity). For 3 treated subjects in the Liquid GBS trivalent vaccine group, no safety data were available and for 4 subjects from both groups, no solicited safety data were reported.

Safety was assessed as the number of subjects who reported solicited local and solicited systemic AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.

Outcome measures

Outcome measures
Measure	Liquid GBS Trivalent Vaccine n=524 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=519 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Headache	176 Participants	187 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Any local AEs	247 Participants	229 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Injection site Erythema	16 Participants	9 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Injection site Induration	17 Participants	15 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Injection site Ecchymosis	1 Participants	6 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Injection site Pain	227 Participants	205 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Injection site Swelling	12 Participants	5 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Injection site Warmth	68 Participants	57 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Chills	64 Participants	56 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Myalgia	75 Participants	78 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Malaise	104 Participants	103 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Nausea	83 Participants	77 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Fatigue	183 Participants	190 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Rash	18 Participants	15 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Arthralgia	49 Participants	53 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Fever (≥38°C)	8 Participants	7 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Analgesic/antipyrectic use (prevention)	2 Participants	3 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Analgesic/antipyrectic use (treatment)	59 Participants	69 Participants
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) Any Systemic AEs	280 Participants	278 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 181 (end of the study)

Population: Analyses were evaluated on the Unsolicited AEs Safety Set (i.e. all subjects in the exposed set who provided information about post vaccination unsolicited AEs). There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.

Safety was assessed as the number of subjects who reported unsolicited AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.

Outcome measures

Outcome measures
Measure	Liquid GBS Trivalent Vaccine n=526 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=521 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Number of Subjects Reporting Any Unsolicited AEs Any AEs	272 Subjects	276 Subjects
Number of Subjects Reporting Any Unsolicited AEs At least possibly or probably related AEs	57 Subjects	52 Subjects
Number of Subjects Reporting Any Unsolicited AEs Medically attended AEs	165 Subjects	166 Subjects
Number of Subjects Reporting Any Unsolicited AEs AEs leading to Withdrawal	0 Subjects	0 Subjects
Number of Subjects Reporting Any Unsolicited AEs AEs leading to Hospitalization	5 Subjects	9 Subjects
Number of Subjects Reporting Any Unsolicited AEs AEs leading to Death	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: From Day 1 to Day 181 (end of the study)

Safety was assessed as the number of subjects who reported SAEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.

Outcome measures

Outcome measures
Measure	Liquid GBS Trivalent Vaccine n=526 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=521 Participants Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Number of Subjects Reporting Any Serious Adverse Events (SAEs) Serious AEs	6 Subjects	9 Subjects
Number of Subjects Reporting Any Serious Adverse Events (SAEs) At least possibly or probably related SAEs	0 Subjects	0 Subjects

Adverse Events

Liquid GBS Trivalent Vaccine

Serious events: 6 serious events

Other events: 439 other events

Deaths: 0 deaths

Lyophilized GBS Trivalent Vaccine

Serious events: 9 serious events

Other events: 430 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Liquid GBS Trivalent Vaccine n=526 participants at risk Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=521 participants at risk Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Gastrointestinal disorders Nausea	16.3% 86/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	15.5% 81/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Chills	12.7% 67/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	10.9% 57/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Fatigue	35.4% 186/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	37.2% 194/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Injection site erythema	16.7% 88/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	16.1% 84/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Injection site haemorrhage	6.3% 33/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	7.3% 38/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Injection site induration	13.1% 69/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	11.5% 60/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Injection site pain	45.2% 238/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	42.2% 220/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Injection site swelling	8.0% 42/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	6.1% 32/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Injection site warmth	13.9% 73/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	10.9% 57/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
General disorders Malaise	20.0% 105/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	20.0% 104/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Infections and infestations Upper respiratory tract infection	7.4% 39/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	4.4% 23/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 55/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	10.9% 57/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Musculoskeletal and connective tissue disorders Myalgia	14.4% 76/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	15.4% 80/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Nervous system disorders Headache	35.7% 188/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	39.9% 208/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.

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

Measure	Liquid GBS Trivalent Vaccine n=526 participants at risk Healthy non-pregnant women aged 18-40 years that received a single dose of liquid GBS trivalent vaccine	Lyophilized GBS Trivalent Vaccine n=521 participants at risk Healthy non-pregnant women aged 18-40 years that received a single dose of lyophilized GBS trivalent vaccine
Gastrointestinal disorders Abdominal adhesions	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Gastrointestinal disorders Nausea	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Gastrointestinal disorders Vomiting	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Infections and infestations Gastroenteritis	0.19% 1/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.00% 0/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Infections and infestations Gastroenteritis viral	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Infections and infestations Pharyngitis	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Injury, poisoning and procedural complications Ligament rupture	0.19% 1/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.00% 0/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Injury, poisoning and procedural complications Meniscus injury	0.19% 1/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.00% 0/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.19% 1/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.00% 0/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Psychiatric disorders Acute psychosis	0.19% 1/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.00% 0/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Psychiatric disorders Major depression	0.00% 0/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.19% 1/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Reproductive system and breast disorders Cervical dysplasia	0.19% 1/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.00% 0/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.
Reproductive system and breast disorders Endometriosis	0.19% 1/526 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.	0.00% 0/521 • Solicited local and systemic adverse events (AEs) were collected from Day 1 through Day 7 after vaccination. All unsolicited AEs and serious adverse events (SAEs)were collected from Day 1 through Day 181 (end of the study). The analyses for serious adverse events and other adverse events were performed on the Unsolicited AEs Safety Set. There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.