Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS

Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.

Study Overview

• Status: Completed
• Conditions: Group B Streptococcus Infections
• Intervention / Treatment: Biological: Multivalent Group B streptococcus vaccine; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1208
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2001
      • Wits Reproductive Health and HIV Institute
    • Soweto, Gauteng, South Africa, 1862
      • Respiratory and Meningeal Pathogens Research Unit (RMPRU)
  • Johannesburg
    • Coronationville, Johannesburg, South Africa, 2093
      • Empilweni Services and Research Unit (ESRU)
  • Johannesburg, Gauteng
    • Parktown, Johannesburg, Gauteng, South Africa, 2196
      • Charlotte Maxeke Johannesburg Academic Hospital
  • Western CAPE
    • Khayelitsha, Western CAPE, South Africa, 7784
      • Michael Mapongwana Community Health Centre
    • Khayelitsha, Western CAPE, South Africa, 7784
      • Site B
    • Khayelitsha, Western CAPE, South Africa, 7784
      • Khayelitsha District Hospital (KDH)
    • Parow Valley, Western CAPE, South Africa, 7505
      • FAMCRU
• United Kingdom
  • Tooting
    • London, Tooting, United Kingdom, SW17 0QT
      • St George's University Hospitals NHS Foundation Trust
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Velocity Clinical Research
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Velocity Clinical Research, Phoenix
  • California
    • Lancaster, California, United States, 93534
      • Chemidox Clinical Trials Inc.
    • Lancaster, California, United States, 93534
      • Chemidox Clinical Trials Inc
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • Emerson Clinical Research Institute
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
    • Rexburg, Idaho, United States, 83440
      • Clinical Research Prime Rexburg
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • St. Tammany Parish Hospital
    • Covington, Louisiana, United States, 70433
      • Lakeview Regional Medical Center
    • Covington, Louisiana, United States, 70433
      • MedPharmics
    • Hammond, Louisiana, United States, 70403
      • North Oaks Obstetrics & Gynecology
    • Hammond, Louisiana, United States, 70403
      • North Oaks Medical Center
    • Slidell, Louisiana, United States, 70458
      • Velocity Clinical Research
  • Montana
    • Missoula, Montana, United States, 59804
      • Boeson Research
    • Missoula, Montana, United States, 59804
      • Community Hospital
    • Missoula, Montana, United States, 59804
      • The Birth Center
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research
    • Lincoln, Nebraska, United States, 68506
      • Frontier Pediatric Care (Follow-Up Visits for Infant Participants)
    • Lincoln, Nebraska, United States, 68510
      • Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies
  • South Carolina
    • Summerville, South Carolina, United States, 29485
      • Summerville Medical Center
    • Summerville, South Carolina, United States, 29486
      • Coastal Pediatric Research
    • Summerville, South Carolina, United States, 29485
      • Lowcountry Women's Specialists
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Physicians for Women
    • Norfolk, Virginia, United States, 23502
      • Sentara Leigh Hospital
    • Norfolk, Virginia, United States, 23502
      • The Group for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria Stage 1 Nonpregnant Women:

• Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
• Negative urine pregnancy test at Visit 1 (prior to vaccination).
• Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.

Inclusion Criteria Stage 1 Booster Vaccination:

• Participant must have received investigational product at Visit 1.
• Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
• Negative urine pregnancy test at Visit 6 (prior to vaccination).
• Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.

Inclusion Criteria Stage 2 and 3 Maternal Participants:

• Healthy females >=18 and <=40 years of age who are >=27 0/7 (Stage 2) or >=24 0/7 (Stage 3) to <=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
• Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening.

Inclusion Criteria Stage 2 and 3 Infant Participants:

Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.

Exclusion Criteria Stage 1 Nonpregnant Women:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
• History of microbiologically proven invasive disease caused by GBS (S agalactiae).
• Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).

Exclusion criteria Stage 2 and 3 Maternal Participants:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
• History of microbiologically proven invasive disease caused by GBS (S agalactiae).
• Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the participant's participation in the study (through the last blood draw).
• Prepregnancy body mass index (BMI) of ≥40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
• A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation.
• Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.

Exclusion criteria Stage 2 and 3 Infant Participants:

Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1 - Highest dose formulation a; Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Experimental: Stage 1 - Highest dose formulation b; Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Experimental: Stage 2 - Lowest dose formulation a; Multivalent group B streptococcus vaccine - Stage 2 Pregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Experimental: Stage 2 - Lowest dose formulation b; Multivalent group B streptococcus vaccine - Stage 2 Pregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Experimental: Stage 2 - Middle dose formulation a; Multivalent group B streptococcus vaccine - Stage 2 Pregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Experimental: Stage 2 - Middle dose formulation b; Multivalent group B streptococcus vaccine - Stage 2 Pregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Experimental: Stage 2 - Highest dose formulation a; Multivalent group B streptococcus vaccine - Stage 2 Pregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Experimental: Stage 2 - Highest dose formulation b; Multivalent group B streptococcus vaccine - Stage 2 Pregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Experimental: Stage 3 - Selected dose and formulation; Multivalent group B streptococcus vaccine - Stage 3 Pregnant women	Biological: Multivalent Group B streptococcus vaccine; Various formulations at three dose levels
Placebo Comparator: Stage 1 Placebo; Saline control	Biological: Placebo; Saline control
Placebo Comparator: Stage 2 Placebo; Saline control	Biological: Placebo; Saline control
Placebo Comparator: Stage 3 Placebo; Saline control	Biological: Placebo; Saline control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1	Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.	Day 1 (day of vaccination) to Day 7 after Primary Dose
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1	Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.	Day 1 (day of vaccination) to Day 7 after booster dose
Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1	Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.	Day 1 (day of vaccination) to Day 7 after primary dose
Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1	Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.	Day 1 (day of vaccination) to Day 7 after booster dose
Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.	Day 1 (day of vaccination) through 1 Month post primary dose
Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.	Day 1 (day of vaccination) through 1 Month post booster dose
Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.	Day 1 (day of vaccination) through 6 Months post primary dose
Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.	Day 1 (day of vaccination) through 6 Months post primary dose
Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.	Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.	Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose
Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2	Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.	2 weeks after vaccination in Stage 2
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2	Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.	Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3	Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (> 2.5 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.	Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2	Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.	Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3	Systemic events were recorded in e-diary. Fever: oral temperature >=38.0 deg C and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.	Day 1 (day of vaccination) to Day 7 after Vaccination
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.	Day 1 (day of vaccination) through 1 Month post vaccination
Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.	Day 1 (day of vaccination) through 1 Month post vaccination
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.	Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.	Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.	Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.	Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2	Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.	Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3	Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.	Day 1 (day of vaccination) through 12 Month post delivery
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2	Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.	At delivery
Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3	Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.	At delivery
Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2	Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.	At Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2	APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.	At 1 minute of Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2	APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure.	At 5 minutes of Birth
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2	The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.	At Birth
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2	Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.	At Birth
Number of Participants With Vital Status: Infant Participants Stage 2	Participants according to vital status as: live or neonatal death were reported in this outcome measure.	At Birth
Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3	Gestational age of participants at birth in weeks included: greater than or equal to (>=)24 weeks to less than (<) 28 weeks, >=28 weeks to <34 weeks, >=34 weeks to <37 weeks, >=37 weeks to <42 weeks, >=42 weeks.	At 1 minute of Birth
Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3	APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.	At 1 minute of Birth
APGAR Score at 5 Minutes: Infant Participants Stage 3	APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.	At 5 minutes of Birth
Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3	The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at <37 weeks 0 days, >=37 weeks to <42 weeks, >=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.	At Birth
Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3	Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.	At 5 minutes of Birth
Number of Participants With Vital Status: Infant Participants Stage 3	Participants according to vital status as: live or neonatal death were reported in this outcome measure.	At Birth
Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.	From Birth to 6 Weeks
Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.	From Birth to 6 Weeks
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.	From Birth to 12 Months
Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.	From Birth to 12 Months
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.	From Birth to 12 Months
Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.	From Birth to 12 Months
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.	From Birth to 12 Months
Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3	An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.	From Birth to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	At 1 Month After primary Dose
GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery
GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2	OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.	At 1 Month After Vaccination and at Delivery
GBS6 Serotype-Specific OPA Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3	OPA for the 6 serotypes (Ia, Ib, II, III, IV, V) were determined in all participants for each blood sample.	At 1 Month After Vaccination and at Delivery
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 2	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	At Birth
GMCs of GBS6 Serotype-Specific IgG Infant Participant at Birth: Infant Participants Stage 3	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	At Birth
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 2	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	At Birth
GBS6 Serotype-Specific OPA GMTs Measured at Birth: Infant Participants Stage 3	Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.	At Birth

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): March 4, 2024
• Study Completion (Actual): March 4, 2024

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections
• Other Study ID Numbers: C1091002; 2020-005074-96 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No