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

This study has been completed.

Sponsor:

Collaborator:

Novartis Vaccines

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT02046148

First received: January 21, 2014

Last updated: April 20, 2017

Last verified: February 2017

History of Changes

Results First Received: January 31, 2017

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Care Provider, Investigator, Outcomes Assessor; Primary Purpose: Prevention
Condition:	GBS Disease
Interventions:	Biological: GBS trivalent vaccine Biological: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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).

Participant Flow: Overall Study

	GBS Group	Placebo Group
STARTED	49	26
COMPLETED	48	23
NOT COMPLETED	1	3
Lost to Follow-up	1	1
Withdrawal by Subject	0	2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
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).
Total	Total of all reporting groups

Baseline Measures

	GBS Group	Placebo Group	Total
Overall Participants Analyzed [Units: Participants]	49	26	75

Age [Units: Years] Mean (Standard Deviation)	29.4 (4.2)	29.4 (5.1)	29.4 (4.5)

Sex: Female, Male [Units: Participants] Count of Participants
Female	49 100.0%	26 100.0%	75 100.0%
Male	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

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1. Primary:

Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age [ Time Frame: At Birth, Day 42 and Day 90 ]

Measure Type	Primary
Measure Title	Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Measure Description	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).
Time Frame	At Birth, Day 42 and Day 90

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	44	23
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age [Units: µg/mL] Geometric Mean (95% Confidence Interval)
Anti-Ia Birth
Participants Analyzed [Units: Participants]	44	23
Anti-Ia Birth	6.98 (3.09 to 16)	0.24 (0.085 to 0.69)
Anti-Ia Day 42
Participants Analyzed [Units: Participants]	38	19
Anti-Ia Day 42	6.18 (2.6 to 15)	0.39 (0.12 to 1.23)
Anti-Ia Day 90
Participants Analyzed [Units: Participants]	37	16
Anti-Ia Day 90	2.74 (1.2 to 6.28)	0.33 (0.11 to 0.98)

No statistical analysis provided for Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age

2. Primary:

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 [ Time Frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ]

Measure Type	Primary
Measure Title	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
Measure Description	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).
Time Frame	At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
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 [Units: µg/mL] Geometric Mean (95% Confidence Interval)
Anti-Ia Day 1 pre-vaccination
Participants Analyzed [Units: Participants]	48	26
Anti-Ia Day 1 pre-vaccination	0.49 (0.29 to 0.82)	0.33 (0.18 to 0.62)
Anti-Ia Day 31 post-vaccination
Participants Analyzed [Units: Participants]	43	25
Anti-Ia Day 31 post-vaccination	8.99 (4.7 to 17)	0.4 (0.18 to 0.85)
Anti-Ia Delivery
Participants Analyzed [Units: Participants]	40	25
Anti-Ia Delivery	5.37 (2.97 to 9.71)	0.36 (0.18 to 0.71)
Anti-Ia Day 42 postpartum
Participants Analyzed [Units: Participants]	41	22
Anti-Ia Day 42 postpartum	13 (6.91 to 24)	0.64 (0.3 to 1.4)
Anti-Ia Day 90 postpartum
Participants Analyzed [Units: Participants]	44	19
Anti-Ia Day 90 postpartum	8.38 (4.42 to 16)	0.58 (0.25 to 1.35)

No statistical analysis provided for 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

3. Primary:

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 [ Time Frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ]

Measure Type	Primary
Measure Title	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
Measure Description	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).
Time Frame	At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	44	25
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 [Units: Ratio] Geometric Mean (95% Confidence Interval)
Anti-Ia Day 31/Day 1
Participants Analyzed [Units: Participants]	43	25
Anti-Ia Day 31/Day 1	25 (13 to 49)	1.05 (0.49 to 2.26)
Anti-Ia Delivery/Day 1
Participants Analyzed [Units: Participants]	40	25
Anti-Ia Delivery/Day 1	16 (8.85 to 29)	1.03 (0.52 to 2.04)
Anti-Ia Day 42/Day 1
Participants Analyzed [Units: Participants]	41	22
Anti-Ia Day 42/Day 1	32 (18 to 59)	1.55 (0.71 to 3.36)
Anti-Ia Day 90/Day 1
Participants Analyzed [Units: Participants]	44	19
Anti-Ia Day 90/Day 1	23 (12 to 43)	1.5 (0.64 to 3.52)

No statistical analysis provided for 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

4. Secondary:

Ratio of GBS IgG Antibody Levels – Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery [ Time Frame: At Delivery ]

Measure Type	Secondary
Measure Title	Ratio of GBS IgG Antibody Levels – Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery
Measure Description	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).
Time Frame	At Delivery

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	38	22
Ratio of GBS IgG Antibody Levels – Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery [Units: Ratio] Geometric Mean (95% Confidence Interval)	0.75 (0.63 to 0.89)	0.86 (0.69 to 1.07)

No statistical analysis provided for Ratio of GBS IgG Antibody Levels – Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery

5. Secondary:

Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes [ Time Frame: Up to 30 minutes post-vaccination ]

Measure Type	Secondary
Measure Title	Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes
Measure Description	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.
Time Frame	Up to 30 minutes post-vaccination

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes [Units: Percentage of Maternal Subjects]
Local Ecchymosis	0	0
Local Erythema	0	0
Local Induration	0	0
Local Swelling	0	0
Local Pain	3	2
Local Warmth	0	0
Systemic Arthralgia	0	0
Systemic Chills	0	0
Systemic Fatigue	0	0
Systemic Headache	1	0
Systemic Change in eating Habits	0	0
Systemic Myalgia	1	0
Systemic Nausea	1	0
Systemic Rash	0	0
Systemic Urticaria	0	0
Systemic Fever (≥ 38°C)	0	0

No statistical analysis provided for Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes

6. Secondary:

Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 [ Time Frame: During Study Days 1-3 (from 6 hours through Day 3 post-vaccination) ]

Measure Type	Secondary
Measure Title	Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3
Measure Description	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.
Time Frame	During Study Days 1-3 (from 6 hours through Day 3 post-vaccination)

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 [Units: Percentage of Maternal Subjects]
Local Ecchymosis
Participants Analyzed [Units: Participants]	48	25
Local Ecchymosis	0	0
Local Erythema
Participants Analyzed [Units: Participants]	48	25
Local Erythema	0	0
Local Induration
Participants Analyzed [Units: Participants]	48	26
Local Induration	0	0
Local Swelling
Participants Analyzed [Units: Participants]	48	26
Local Swelling	0	0
Local Pain
Participants Analyzed [Units: Participants]	48	26
Local Pain	24	8
Local Warmth
Participants Analyzed [Units: Participants]	48	26
Local Warmth	3	0
Systemic Arthralgia
Participants Analyzed [Units: Participants]	48	26
Systemic Arthralgia	1	2
Systemic Chills
Participants Analyzed [Units: Participants]	48	25
Systemic Chills	0	1
Systemic Fatigue
Participants Analyzed [Units: Participants]	48	26
Systemic Fatigue	13	6
Systemic Headache
Participants Analyzed [Units: Participants]	48	26
Systemic Headache	5	3
Systemic Loss of appetite
Participants Analyzed [Units: Participants]	48	26
Systemic Loss of appetite	4	2
Systemic Myalgia
Participants Analyzed [Units: Participants]	48	26
Systemic Myalgia	1	2
Systemic Nausea
Participants Analyzed [Units: Participants]	48	26
Systemic Nausea	7	2
Systemic Rash
Participants Analyzed [Units: Participants]	48	26
Systemic Rash	1	0
Systemic Urticaria
Participants Analyzed [Units: Participants]	48	26
Systemic Urticaria	1	0
Systemic Fever (≥ 38°C)
Participants Analyzed [Units: Participants]	48	26
Systemic Fever (≥ 38°C)	0	0

No statistical analysis provided for Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3

7. Secondary:

Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7 [ Time Frame: During Study Days 4-7 ]

Measure Type	Secondary
Measure Title	Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7
Measure Description	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.
Time Frame	During Study Days 4-7

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7 [Units: Percentage of Maternal Subjects]
Local Ecchymosis
Participants Analyzed [Units: Participants]	48	25
Local Ecchymosis	0	0
Local Erythema
Participants Analyzed [Units: Participants]	48	25
Local Erythema	0	0
Local Induration
Participants Analyzed [Units: Participants]	48	26
Local Induration	0	0
Local Swelling
Participants Analyzed [Units: Participants]	48	26
Local Swelling	0	0
Local Pain
Participants Analyzed [Units: Participants]	48	26
Local Pain	5	1
Local Warmth
Participants Analyzed [Units: Participants]	48	26
Local Warmth	0	0
Systemic Arthralgia
Participants Analyzed [Units: Participants]	48	26
Systemic Arthralgia	1	1
Systemic Chills
Participants Analyzed [Units: Participants]	48	25
Systemic Chills	1	0
Systemic Fatigue
Participants Analyzed [Units: Participants]	48	26
Systemic Fatigue	8	2
Systemic Headache
Participants Analyzed [Units: Participants]	48	26
Systemic Headache	3	2
Systemic Loss of appetite
Participants Analyzed [Units: Participants]	48	26
Systemic Loss of appetite	2	1
Systemic Myalgia
Participants Analyzed [Units: Participants]	48	26
Systemic Myalgia	1	1
Systemic Nausea
Participants Analyzed [Units: Participants]	48	26
Systemic Nausea	1	1
Systemic Rash
Participants Analyzed [Units: Participants]	48	26
Systemic Rash	0	0
Systemic Urticaria
Participants Analyzed [Units: Participants]	48	26
Systemic Urticaria	0	0
Systemic Fever (≥ 38°C)
Participants Analyzed [Units: Participants]	48	26
Systemic Fever (≥ 38°C)	0	0

No statistical analysis provided for Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7

8. Secondary:

Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 [ Time Frame: During Study Days 1-7 (from 6 hours through Day 7 post-vaccination) ]

Measure Type	Secondary
Measure Title	Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7
Measure Description	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.
Time Frame	During Study Days 1-7 (from 6 hours through Day 7 post-vaccination)

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 [Units: Percentage of Maternal Subjects]
Local Ecchymosis
Participants Analyzed [Units: Participants]	48	25
Local Ecchymosis	0	0
Local Erythema
Participants Analyzed [Units: Participants]	48	25
Local Erythema	0	0
Local Induration
Participants Analyzed [Units: Participants]	48	26
Local Induration	0	0
Local Swelling
Participants Analyzed [Units: Participants]	48	26
Local Swelling	0	0
Local Pain
Participants Analyzed [Units: Participants]	48	26
Local Pain	24	8
Local Warmth
Participants Analyzed [Units: Participants]	48	26
Local Warmth	3	0
Systemic Arthralgia
Participants Analyzed [Units: Participants]	48	26
Systemic Arthralgia	2	2
Systemic Chills
Participants Analyzed [Units: Participants]	48	25
Systemic Chills	1	1
Systemic Fatigue
Participants Analyzed [Units: Participants]	48	26
Systemic Fatigue	18	6
Systemic Headache
Participants Analyzed [Units: Participants]	48	26
Systemic Headache	6	3
Systemic Loss of appetite
Participants Analyzed [Units: Participants]	48	26
Systemic Loss of appetite	6	2
Systemic Myalgia
Participants Analyzed [Units: Participants]	48	26
Systemic Myalgia	2	2
Systemic Nausea
Participants Analyzed [Units: Participants]	48	26
Systemic Nausea	7	3
Systemic Rash
Participants Analyzed [Units: Participants]	48	26
Systemic Rash	1	0
Systemic Urticaria
Participants Analyzed [Units: Participants]	48	26
Systemic Urticaria	1	0
Systemic Fever (≥ 38°C)
Participants Analyzed [Units: Participants]	48	26
Systemic Fever (≥ 38°C)	0	0

No statistical analysis provided for Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7

9. Secondary:

Percentage of Maternal Subjects With Any Unsolicited AEs [ Time Frame: From Study Day 1 through Study Day 31 ]

Measure Type	Secondary
Measure Title	Percentage of Maternal Subjects With Any Unsolicited AEs
Measure Description	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.
Time Frame	From Study Day 1 through Study Day 31

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	49	26
Percentage of Maternal Subjects With Any Unsolicited AEs [Units: Percentage of Maternal Subjects]	18	6

No statistical analysis provided for Percentage of Maternal Subjects With Any Unsolicited AEs

10. Secondary:

Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) [ Time Frame: From Study Day 1 through Study Day 31 ]

Measure Type	Secondary
Measure Title	Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)
Measure Description	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.
Time Frame	From Study Day 1 through Study Day 31

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	49	26
Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) [Units: Percentage of Maternal Subjects]
Any SAE from Day 1 to Day 31	1	0
Any MAE from Day 1 to Day 31	10	4
Any AE lead. Wthwal Day 1 to Day 31	0	0

No statistical analysis provided for Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)

11. Secondary:

Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) [ Time Frame: From Study Day 32 through Day 180 postpartum ]

Measure Type	Secondary
Measure Title	Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)
Measure Description	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.
Time Frame	From Study Day 32 through Day 180 postpartum

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	49	26
Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) [Units: Percentage of Maternal Subjects]
Any SAE from Day 32 to Day 180	7	4
Any MAE from Day 32 to Day 180	38	17
Any AE lead. Wthwal Day 32 to Day 180	0	0

No statistical analysis provided for Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)

12. Secondary:

Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal [ Time Frame: From Birth through Day 180 of age ]

Measure Type	Secondary
Measure Title	Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal
Measure Description	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.
Time Frame	From Birth through Day 180 of age

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal [Units: Percentage of Infant Subjects]
Any SAE	7	3
Any MAE	34	15
Any AE lead. Wthwal	0	0

No statistical analysis provided for Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal

13. Secondary:

Birth Weight of Infants (Mean-Standard Deviation) [ Time Frame: At Birth ]

Measure Type	Secondary
Measure Title	Birth Weight of Infants (Mean-Standard Deviation)
Measure Description	Weight at birth was summarized by reporting the mean and standard deviation,
Time Frame	At Birth

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Birth Weight of Infants (Mean-Standard Deviation) [Units: Kilogram] Mean (Standard Deviation)	3.44 (0.45)	3.32 (0.40)

No statistical analysis provided for Birth Weight of Infants (Mean-Standard Deviation)

14. Secondary:

Birth Weight of Infants (Median, Minimum and Maximum) [ Time Frame: At Birth ]

Measure Type	Secondary
Measure Title	Birth Weight of Infants (Median, Minimum and Maximum)
Measure Description	Weight at birth was summarized by reporting the median and the minimum and maximum.
Time Frame	At Birth

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Birth Weight of Infants (Median, Minimum and Maximum) [Units: Kilogram] Median (Full Range)	3.5 (2.3 to 4.5)	3.3 (2.7 to 4.4)

No statistical analysis provided for Birth Weight of Infants (Median, Minimum and Maximum)

15. Secondary:

Birth Length and Head Circumference of Infants (Mean - Standard Deviation) [ Time Frame: At Birth ]

Measure Type	Secondary
Measure Title	Birth Length and Head Circumference of Infants (Mean - Standard Deviation)
Measure Description	Length and head circumference at birth were summarized by reporting the mean and standard deviation.
Time Frame	At Birth

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	46	25
Birth Length and Head Circumference of Infants (Mean - Standard Deviation) [Units: Centimeter] Mean (Standard Deviation)
Lenght mean	51.35 (2.26)	49.70 (2.17)
Head circumference mean	34.4 (1.51)	34.48 (1.08)

No statistical analysis provided for Birth Length and Head Circumference of Infants (Mean - Standard Deviation)

16. Secondary:

Birth Length and Head Circumference of Infants (Median - Minimum and Maximum) [ Time Frame: At birth ]

Measure Type	Secondary
Measure Title	Birth Length and Head Circumference of Infants (Median - Minimum and Maximum)
Measure Description	Length and head circumference at birth were summarized by reporting the median and minimum and maximum
Time Frame	At birth

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	46	25
Birth Length and Head Circumference of Infants (Median - Minimum and Maximum) [Units: Centimeter] Median (Full Range)
Lengh Median	52.0 (45.0 to 56.0)	50.0 (45.7 to 55.0)
Head circumference Median	35.0 (32.0 to 37.0)	34.0 (33.0 to 37.0)

No statistical analysis provided for Birth Length and Head Circumference of Infants (Median - Minimum and Maximum)

17. Secondary:

Infants Apgar Scores (Mean - Standard Deviation) [ Time Frame: At 1, 5 and 10 minutes ]

Measure Type	Secondary
Measure Title	Infants Apgar Scores (Mean - Standard Deviation)
Measure Description	Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar score between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.
Time Frame	At 1, 5 and 10 minutes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Infants Apgar Scores (Mean - Standard Deviation) [Units: Scores on a scale] Mean (Standard Deviation)
Mean 1 minute
Participants Analyzed [Units: Participants]	48	26
Mean 1 minute	8.13 (1.16)	8.23 (0.51)
Mean 5 minutes
Participants Analyzed [Units: Participants]	47	26
Mean 5 minutes	8.89 (0.48)	8.88 (0.43)
Mean 10 minutes
Participants Analyzed [Units: Participants]	2	1
Mean 10 minutes	8.5 (0.71)	9.0 ^[1]

[1]	Standard Deviation indeterminated (denominator =0)

No statistical analysis provided for Infants Apgar Scores (Mean - Standard Deviation)

18. Secondary:

Infants Apgar Scores (Median, Minimum and Maximum) [ Time Frame: At 1, 5 and 10 minutes ]

Measure Type	Secondary
Measure Title	Infants Apgar Scores (Median, Minimum and Maximum)
Measure Description	Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar scores between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.
Time Frame	At 1, 5 and 10 minutes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	26
Infants Apgar Scores (Median, Minimum and Maximum) [Units: Scores on a scale] Median (Full Range)
Median 1 minute
Participants Analyzed [Units: Participants]	48	26
Median 1 minute	8.0 (1.0 to 9.0)	8.0 (7.0 to 9.0)
Median 5 minutes
Participants Analyzed [Units: Participants]	47	26
Median 5 minutes	9.0 (7.0 to 10)	9.0 (8.0 to 10)
Median 10 minutes
Participants Analyzed [Units: Participants]	2	1
Median 10 minutes	8.5 (8.0 to 9.0)	9.0 (9.0 to 9.0)

No statistical analysis provided for Infants Apgar Scores (Median, Minimum and Maximum)

19. Secondary:

Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation) [ Time Frame: At Day 180 of age ]

Measure Type	Secondary
Measure Title	Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation)
Measure Description	Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross). Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the mean and standard deviation.
Time Frame	At Day 180 of age

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	23
Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation) [Units: Scores on a scale] Mean (Standard Deviation)
Cognitive mean	11.2 (1.7)	11.7 (2.0)
Receptive Communication mean	8.8 (2.0)	9.8 (2.5)
Expressive Communication mean	8.4 (2.0)	8.9 (2.0)
Fine Motor mean	9.0 (1.5)	9.5 (1.5)
Gross Motor mean	9.8 (1.9)	10.3 (2.0)

No statistical analysis provided for Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation)

20. Secondary:

Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum) [ Time Frame: At Day 180 of age ]

Measure Type	Secondary
Measure Title	Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum)
Measure Description	Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross). Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the median, minimum and maximum.
Time Frame	At Day 180 of age

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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).

Measured Values

	GBS Group	Placebo Group
Participants Analyzed [Units: Participants]	48	23
Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum) [Units: Sores on a scale] Median (Full Range)
Cognitive median	11.0 (7 to 15)	12.0 (8 to 16)
Receptive Communication median	8.0 (5 to 12)	9.0 (6 to 14)
Expressive Communication median	8.5 (5 to 13)	9.0 (5 to 11)
Fine Motor median	9.0 (6 to 12)	10.0 (7 to 13)
Gross Motor median	10.0 (3 to 15)	11.0 (7 to 14)

21. Primary:

Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age [ Time Frame: At Birth, Day 42 and Day 90 ]