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

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
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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

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%

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 ]

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) ]

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) ]

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 ]

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 ]

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) ]

7.  Secondary:

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

9.  Secondary:

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

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 ]

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 ]

12.  Secondary:

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

13.  Secondary:

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

14.  Secondary:

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

15.  Secondary:

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

16.  Secondary:

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

17.  Secondary:

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

18.  Secondary:

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

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 ]

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 ]

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 ]

22.  Primary:

Concentration of Serotype III 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 ]

23.  Primary:

Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum   [ Time Frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ]

24.  Primary:

Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum   [ Time Frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ]

25.  Primary:

Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels – Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum   [ Time Frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ]

26.  Primary:

Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels – Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum   [ Time Frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ]

27.  Secondary:

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

28.  Secondary:

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

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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