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
NCT ID: NCT03765073
Last Updated: 2025-08-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1208 participants
INTERVENTIONAL
2019-01-14
2024-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
DOUBLE
Study Groups
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Stage 1 - Highest dose formulation a
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 1 - Highest dose formulation b
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Lowest dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Lowest dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Middle dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Middle dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Highest dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 2 - Highest dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 3 - Selected dose and formulation
Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Stage 1 Placebo
Saline control
Placebo
Saline control
Stage 2 Placebo
Saline control
Placebo
Saline control
Stage 3 Placebo
Saline control
Placebo
Saline control
Interventions
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Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
Placebo
Saline control
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* 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.
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
* 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).
* 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.
Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
0 Years
40 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Velocity Clinical Research
Mobile, Alabama, United States
Velocity Clinical Research, Phoenix
Phoenix, Arizona, United States
Chemidox Clinical Trials Inc.
Lancaster, California, United States
Chemidox Clinical Trials Inc
Lancaster, California, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Clinical Research Prime Rexburg
Rexburg, Idaho, United States
Lakeview Regional Medical Center
Covington, Louisiana, United States
MedPharmics
Covington, Louisiana, United States
St. Tammany Parish Hospital
Covington, Louisiana, United States
North Oaks Medical Center
Hammond, Louisiana, United States
North Oaks Obstetrics & Gynecology
Hammond, Louisiana, United States
Velocity Clinical Research
Slidell, Louisiana, United States
Boeson Research
Missoula, Montana, United States
Community Hospital
Missoula, Montana, United States
The Birth Center
Missoula, Montana, United States
Meridian Clinical Research
Hastings, Nebraska, United States
Frontier Pediatric Care (Follow-Up Visits for Infant Participants)
Lincoln, Nebraska, United States
Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)
Lincoln, Nebraska, United States
Be Well Clinical Studies
Lincoln, Nebraska, United States
Lowcountry Women's Specialists
Summerville, South Carolina, United States
Summerville Medical Center
Summerville, South Carolina, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
Sentara Leigh Hospital
Norfolk, Virginia, United States
The Group for Women
Norfolk, Virginia, United States
Tidewater Physicians for Women
Norfolk, Virginia, United States
Wits Reproductive Health and HIV Institute
Johannesburg, Gauteng, South Africa
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
Soweto, Gauteng, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, South Africa
Empilweni Services and Research Unit (ESRU)
Coronationville, Johannesburg, South Africa
Khayelitsha District Hospital (KDH)
Khayelitsha, Western Cape, South Africa
Michael Mapongwana Community Health Centre
Khayelitsha, Western Cape, South Africa
Site B
Khayelitsha, Western Cape, South Africa
FAMCRU
Parow Valley, Western Cape, South Africa
St George's University Hospitals NHS Foundation Trust
London, Tooting, United Kingdom
Countries
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References
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Cutland CL, Sawry S, Fairlie L, Barnabas S, Frajzyngier V, Roux JL, Izu A, Kekane-Mochwari KE, Vika C, De Jager J, Munson S, Jongihlati B, Stark JH, Absalon J. Obstetric and neonatal outcomes in South Africa. Vaccine. 2024 Feb 27;42(6):1352-1362. doi: 10.1016/j.vaccine.2024.01.054. Epub 2024 Feb 3.
Madhi SA, Anderson AS, Absalon J, Radley D, Simon R, Jongihlati B, Strehlau R, van Niekerk AM, Izu A, Naidoo N, Kwatra G, Ramsamy Y, Said M, Jones S, Jose L, Fairlie L, Barnabas SL, Newton R, Munson S, Jefferies Z, Pavliakova D, Silmon de Monerri NC, Gomme E, Perez JL, Scott DA, Gruber WC, Jansen KU. Potential for Maternally Administered Vaccine for Infant Group B Streptococcus. N Engl J Med. 2023 Jul 20;389(3):215-227. doi: 10.1056/NEJMoa2116045.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2020-005074-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C1091002
Identifier Type: -
Identifier Source: org_study_id
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