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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02046148
• Collaborator: Novartis Vaccines (Industry)
• Enrollment: 75
• Locations: 6
• Arms: 2
• Actual Duration (Months): 24.3
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.

Condition or Disease	Intervention/Treatment	Phase
GBS Disease; Streptococcus Agalactiae	Biological: GBS trivalent vaccine; Biological: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase II, Multicenter, Randomized, Observer-Blind, Controlled Study to Evaluate Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
• Actual Study Start Date: Mar 18, 2014
• Actual Primary Completion Date: Dec 30, 2015
• Actual Study Completion Date: Mar 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Biological: GBS trivalent vaccine; Intramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein
Active Comparator: 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).	Biological: Placebo; Intramuscular injection - Normal saline

Outcome Measures

Primary Outcome Measures

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

   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).

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

   To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay

3. Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age [At Birth, Day 42 and Day 90]

   To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

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

   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).

5. 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 [At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)]

   To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

6. 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 [At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)]

   To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

7. 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 [At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)]

   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).

8. 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 [At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)]

   Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

9. 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 [At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)]

   Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

Secondary Outcome Measures

1. Ratio of GBS IgG Antibody Levels - Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery [At Delivery]

   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).

2. Ratio of GBS IgG Antibody Levels - Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery [At Delivery]

   To evaluate the relationship of serotype-specific Ib GBS IgG antibody levels (anti-Ib) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

3. Ratio of GBS IgG Antibody Levels - Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery [At Delivery]

   To evaluate the relationship of serotype-specific III GBS IgG antibody levels (anti-III) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.

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

   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.

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

   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.

6. Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7 [During Study Days 4-7]

   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.

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

   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.

8. Percentage of Maternal Subjects With Any Unsolicited AEs [From Study Day 1 through Study Day 31]

   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.

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

   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.

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

    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.

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

    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.

12. Birth Weight of Infants (Mean-Standard Deviation) [At Birth]

    Weight at birth was summarized by reporting the mean and standard deviation,

13. Birth Weight of Infants (Median, Minimum and Maximum) [At Birth]

    Weight at birth was summarized by reporting the median and the minimum and maximum.

14. Birth Length and Head Circumference of Infants (Mean - Standard Deviation) [At Birth]

    Length and head circumference at birth were summarized by reporting the mean and standard deviation.

15. Birth Length and Head Circumference of Infants (Median - Minimum and Maximum) [At birth]

    Length and head circumference at birth were summarized by reporting the median and minimum and maximum

16. Infants Apgar Scores (Mean - Standard Deviation) [At 1, 5 and 10 minutes]

    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.

17. Infants Apgar Scores (Median, Minimum and Maximum) [At 1, 5 and 10 minutes]

    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.

18. 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) [At Day 180 of age]

    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.

19. 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) [At Day 180 of age]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Healthy pregnant women 18-40 years of age, inclusive and at 24 0/7 through 34 6/7 weeks gestation.

2. Individuals who intend to breastfeed for at least 90 days postpartum.

3. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.

4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

5. Individuals who can comprehend and comply with all study procedures and are available for follow-up.

Exclusion Criteria:

1. Individuals with history of illness or an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if she participates in the study.

2. Individuals with known hypersensitivity to any component of the vaccine.

3. Individuals who received or plan to receive any licensed vaccine within 14 days before or after the study vaccine with the exception of inactivated influenza vaccine which may be administered up to 7 days before or after study vaccine.

4. Individuals with an infection requiring systemic antibiotic or antiviral treatment within 7 days prior to Study Day 1.

5. Individuals determined as high risk for serious obstetrical complication, including:

• Gestational hypertension, as defined by American College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin 2012)

• Gestational diabetes which is not controlled by diet and exercise as per American College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin

• Pre-eclampsia or eclampsia as defined by American College of Obstetricians and Gynecologists guidelines (ACOG practice bulletin, 2002)

• HIV infection

• Obesity class II or greater (pre-pregnancy BMI≥35.0)

• multiple pregnancy

1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.

2. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.

3. Individuals with known or suspected impairment of the immune system including known or suspected HIV infection or HIV-related disease, a history of or an active autoimmune disorder and receipt of immunosuppressive therapy.

4. Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 30 days prior to enrollment. Use of inhaled, intranasal, or topical corticosteroids is allowed.

5. Individuals participating in any clinical trial with another investigational product during the pregnancy or intent to participate in another clinical study at any time during the conduct of this study.

6. Pregnant with a fetus with a known or suspected congenital anomaly

7. Individuals who are acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

8. Individuals with a fever (oral temperature ≥ 38°C/100.4 °F) within 3 days prior to intended study vaccination.

9. Individuals with a history of culture confirmed GBS case in the infant(s) previously born to her.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Aurora	Colorado	United States	80045
2	GSK Investigational Site	Baltimore	Maryland	United States	21201
3	GSK Investigational Site	Durham	North Carolina	United States	27705
4	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15213
5	GSK Investigational Site	Charleston	South Carolina	United States	29425
6	GSK Investigational Site	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• GlaxoSmithKline
• Novartis Vaccines

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02046148
• Other Study ID Numbers: 205235; V98_12
• First Posted: Jan 27, 2014
• Last Update Posted: Dec 29, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Maternal vaccine; IgG; IgA; GBS; pregnant women

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled in United States.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Period Title: Overall Study
STARTED	49	26
COMPLETED	48	23
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	GBS Group	Placebo Group	Total
Arm/Group Description	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).	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 of all reporting groups
Overall Participants	49	26	75
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	29.4 (4.2)	29.4 (5.1)	29.4 (4.5)
Sex: Female, Male (Count of Participants)
Female	49 100%	26 100%	75 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	44	23
Anti-Ia Birth	6.98	0.24
Anti-Ia Day 42	6.18	0.39
Anti-Ia Day 90	2.74	0.33

2. Primary Outcome

Title	Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Description	To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay
Time Frame	At Birth, Day 42 and Day 90

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	41	23
Anti-Ib Birth	4.65	0.6
Anti-Ib Day 42	3.02	0.63
Anti-Ib Day 90	1.81	0.52

3. Primary Outcome

Title	Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Description	To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time Frame	At Birth, Day 42 and Day 90

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	40	22
Anti-III Birth	7.97	0.21
Anti-III Day 42	2.64	0.25
Anti-III Day 90	2.01	0.22

4. Primary Outcome

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
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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Anti-Ia Day 1 pre-vaccination	0.49	0.33
Anti-Ia Day 31 post-vaccination	8.99	0.4
Anti-Ia Delivery	5.37	0.36
Anti-Ia Day 42 postpartum	13	0.64
Anti-Ia Day 90 postpartum	8.38	0.58

5. Primary Outcome

Title	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
Description	To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time Frame	At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	47	26
Anti-Ib Day 1 pre-vaccination	0.34	0.42
Anti-Ib Day 31 post-vaccination	7.32	0.47
Anti-Ib Delivery	5.59	0.41
Anti-Ib Day 42 postpartum	8.9	0.61
Anti-Ib Day 90 postpartum	6.15	0.53

6. Primary Outcome

Title	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
Description	To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time Frame	At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	43	25
Anti-III Day 1 pre-vaccination	0.31	0.19
Anti-III Day 31 post-vaccination	3.61	0.28
Anti-III Delivery	4.4	0.27
Anti-III Day 42 postpartum	3.74	0.26
Anti-III Day 90 postpartum	4.04	0.3

7. Primary Outcome

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
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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	44	25
Anti-Ia Day 31/Day 1	25	1.05
Anti-Ia Delivery/Day 1	16	1.03
Anti-Ia Day 42/Day 1	32	1.55
Anti-Ia Day 90/Day 1	23	1.5

8. Primary Outcome

Title	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
Description	Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time Frame	At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	41	25
Anti-Ib Day 31/Day 1	21	1.39
Anti-Ib Delivery/Day 1	16	1.28
Anti-Ib Day 42/Day 1	28	1.9
Anti-Ib Day 90/Day 1	20	1.75

9. Primary Outcome

Title	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
Description	Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time Frame	At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	37	24
Anti-III Day 31/Day 1	16	0.97
Anti-III Delivery/Day 1	21	0.98
Anti-III Day 42/Day 1	16	0.99
Anti-III Day 90/Day 1	16	0.98

10. Secondary Outcome

Title	Ratio of GBS IgG Antibody Levels - Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	38	22
Geometric Mean (95% Confidence Interval) [Ratio]	0.75	0.86

11. Secondary Outcome

Title	Ratio of GBS IgG Antibody Levels - Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery
Description	To evaluate the relationship of serotype-specific Ib GBS IgG antibody levels (anti-Ib) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time Frame	At Delivery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	34	22
Geometric Mean (95% Confidence Interval) [Ratio]	0.82	0.95

12. Secondary Outcome

Title	Ratio of GBS IgG Antibody Levels - Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery
Description	To evaluate the relationship of serotype-specific III GBS IgG antibody levels (anti-III) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.
Time Frame	At Delivery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	32	21
Geometric Mean (95% Confidence Interval) [Ratio]	0.62	0.87

13. Secondary Outcome

Title	Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
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

14. Secondary Outcome

Title	Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3
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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Local Ecchymosis	0	0
Local Erythema	0	0
Local Induration	0	0
Local Swelling	0	0
Local Pain	24	8
Local Warmth	3	0
Systemic Arthralgia	1	2
Systemic Chills	0	1
Systemic Fatigue	13	6
Systemic Headache	5	3
Systemic Loss of appetite	4	2
Systemic Myalgia	1	2
Systemic Nausea	7	2
Systemic Rash	1	0
Systemic Urticaria	1	0
Systemic Fever (≥ 38°C)	0	0

15. Secondary Outcome

Title	Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Local Ecchymosis	0	0
Local Erythema	0	0
Local Induration	0	0
Local Swelling	0	0
Local Pain	5	1
Local Warmth	0	0
Systemic Arthralgia	1	1
Systemic Chills	1	0
Systemic Fatigue	8	2
Systemic Headache	3	2
Systemic Loss of appetite	2	1
Systemic Myalgia	1	1
Systemic Nausea	1	1
Systemic Rash	0	0
Systemic Urticaria	0	0
Systemic Fever (≥ 38°C)	0	0

16. Secondary Outcome

Title	Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7
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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Local Ecchymosis	0	0
Local Erythema	0	0
Local Induration	0	0
Local Swelling	0	0
Local Pain	24	8
Local Warmth	3	0
Systemic Arthralgia	2	2
Systemic Chills	1	1
Systemic Fatigue	18	6
Systemic Headache	6	3
Systemic Loss of appetite	6	2
Systemic Myalgia	2	2
Systemic Nausea	7	3
Systemic Rash	1	0
Systemic Urticaria	1	0
Systemic Fever (≥ 38°C)	0	0

17. Secondary Outcome

Title	Percentage of Maternal Subjects With Any Unsolicited AEs
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	49	26
Number [Percentage of Maternal Subjects]	18	6

18. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	49	26
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

19. Secondary Outcome

Title	Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	49	26
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

20. Secondary Outcome

Title	Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Any SAE	7	3
Any MAE	34	15
Any AE lead. Wthwal	0	0

21. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Mean (Standard Deviation) [Kilogram]	3.44 (0.45)	3.32 (0.40)

22. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Median (Full Range) [Kilogram]	3.5	3.3

23. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	46	25
Lenght mean	51.35 (2.26)	49.70 (2.17)
Head circumference mean	34.4 (1.51)	34.48 (1.08)

24. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	46	25
Lengh Median	52.0	50.0
Head circumference Median	35.0	34.0

25. Secondary Outcome

Title	Infants Apgar Scores (Mean - Standard Deviation)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Mean 1 minute	8.13 (1.16)	8.23 (0.51)
Mean 5 minutes	8.89 (0.48)	8.88 (0.43)
Mean 10 minutes	8.5 (0.71)	9.0 (NA)

26. Secondary Outcome

Title	Infants Apgar Scores (Median, Minimum and Maximum)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	26
Median 1 minute	8.0	8.0
Median 5 minutes	9.0	9.0
Median 10 minutes	8.5	9.0

27. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	23
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)

28. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GBS Group	Placebo Group
Arm/Group Description	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).	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).
Measure Participants	48	23
Cognitive median	11.0	12.0
Receptive Communication median	8.0	9.0
Expressive Communication median	8.5	9.0
Fine Motor median	9.0	10.0
Gross Motor median	10.0	11.0

Adverse Events

Time Frame	Solicited and Unsolicited AEs within the 31-day post-vaccination period for maternal subjects; SAEs from Study Day 1 to Day 180 postpartum for maternal subjects and from Birth up to Day 180 of age for Infants.
Arm/Group Title	GBS Group		Placebo Group
Arm/Group Description	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).		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).
All Cause Mortality
	GBS Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/26 (0%)
Serious Adverse Events
	GBS Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/49 (16.3%)		4/26 (15.4%)
Blood and lymphatic system disorders
Anaemia	0/49 (0%)	0	1/26 (3.8%)	1
Congenital, familial and genetic disorders
Developmental hip dysplasia	1/48 (2.1%)	1	1/26 (3.8%)	1
Polydactyly	1/48 (2.1%)	1	0/26 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/49 (0%)	0	1/26 (3.8%)	1
Hyperbilirubinaemia	1/48 (2.1%)	1	1/26 (3.8%)	1
Infections and infestations
Amniotic cavity infection	1/49 (2%)	1	0/26 (0%)	0
Bronchiolitis	1/48 (2.1%)	1	0/26 (0%)	0
Parainfluenzae virus infection	1/48 (2.1%)	1	0/26 (0%)	0
Urinary tract infection	0/48 (0%)	0	1/26 (3.8%)	1
Metabolism and nutrition disorders
Hypoglycaemia	1/48 (2.1%)	1	0/26 (0%)	0
Pregnancy, puerperium and perinatal conditions
Arrested labour	5/49 (10.2%)	5	0/26 (0%)	0
Breech presentation	0/49 (0%)	0	1/26 (3.8%)	1
Gestational hypertension	1/49 (2%)	1	0/26 (0%)	0
Pre-eclampsia	1/49 (2%)	1	1/26 (3.8%)	2
Premature separation of placenta	1/49 (2%)	1	0/26 (0%)	0
Prolonged labour	1/49 (2%)	1	0/26 (0%)	0
Umbilical cord prolapse	0/49 (0%)	0	1/26 (3.8%)	1
Jaundice neonatal	1/48 (2.1%)	1	0/26 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/49 (0%)	0	1/26 (3.8%)	1
Other (Not Including Serious) Adverse Events
	GBS Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/49 (91.8%)		18/26 (69.2%)
Blood and lymphatic system disorders
ANAEMIA	1/49 (2%)	1	2/26 (7.7%)	2
Gastrointestinal disorders
ABDOMINAL PAIN	3/49 (6.1%)	3	0/26 (0%)	0
NAUSEA	10/49 (20.4%)	11	4/26 (15.4%)	4
General disorders
FATIGUE	18/49 (36.7%)	21	6/26 (23.1%)	7
INJECTION SITE ERYTHEMA	11/49 (22.4%)	13	5/26 (19.2%)	5
INJECTION SITE HAEMORRHAGE	2/49 (4.1%)	2	2/26 (7.7%)	2
INJECTION SITE INDURATION	5/49 (10.2%)	6	2/26 (7.7%)	2
INJECTION SITE PAIN	25/49 (51%)	26	8/26 (30.8%)	8
INJECTION SITE SWELLING	1/49 (2%)	1	3/26 (11.5%)	3
INJECTION SITE WARMTH	3/49 (6.1%)	3	0/26 (0%)	0
Infections and infestations
MASTITIS	3/49 (6.1%)	3	2/26 (7.7%)	2
NASOPHARYNGITIS	2/49 (4.1%)	3	2/26 (7.7%)	2
SINUSITIS	3/49 (6.1%)	3	0/26 (0%)	0
UPPER RESPIRATORY TRACT INFECTION	5/49 (10.2%)	6	0/26 (0%)	0
URINARY TRACT INFECTION	3/49 (6.1%)	3	1/26 (3.8%)	1
Injury, poisoning and procedural complications
PERINEAL INJURY	10/49 (20.4%)	10	5/26 (19.2%)	5
Metabolism and nutrition disorders
DECREASED APPETITE	6/49 (12.2%)	7	2/26 (7.7%)	2
Musculoskeletal and connective tissue disorders
ARTHRALGIA	4/49 (8.2%)	4	2/26 (7.7%)	4
BACK PAIN	3/49 (6.1%)	3	0/26 (0%)	0
MYALGIA	3/49 (6.1%)	3	2/26 (7.7%)	2
Nervous system disorders
HEADACHE	8/49 (16.3%)	11	5/26 (19.2%)	6
Pregnancy, puerperium and perinatal conditions
GESTATIONAL HYPERTENSION	4/49 (8.2%)	4	1/26 (3.8%)	1
OLIGOHYDRAMNIOS	0/49 (0%)	0	2/26 (7.7%)	2
POSTPARTUM HAEMORRHAGE	3/49 (6.1%)	3	4/26 (15.4%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.