BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
NCT ID: NCT07160244
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
6000 participants
INTERVENTIONAL
2025-08-25
2029-03-02
Brief Summary
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This study is seeking healthy pregnant participants:
* aged 49 or younger who can join.
* between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is)
* had a fetal ultrasound examination performed with no major fetal abnormalities observed
* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.
A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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GBS6
Multivalent group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
Placebo
Placebo
Placebo
Saline Control
Infanrix hexa
Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)
Infanrix hexa
Vaccine administered in a subset of infant participants as per the national immunization schedule
Prevenar 20
Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
Prevenar 20
Vaccine administered in a subset of infant participants as per the national immunization schedule
Pediarix
Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio
Pediarix
Vaccine administered in a subset of infant participants as per the national immunization schedule
Prevnar 20
Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
Prevnar 20
Vaccine administered in a subset of infant participants as per the national immunization schedule
Infanrix
Commercially available combination vaccine containing diphtheria, tetanus, and pertussis
Infanrix
Vaccine administered in a subset of infant participants as per the national immunization schedule
Interventions
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Multivalent Group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
Placebo
Saline Control
Infanrix hexa
Vaccine administered in a subset of infant participants as per the national immunization schedule
Prevenar 20
Vaccine administered in a subset of infant participants as per the national immunization schedule
Pediarix
Vaccine administered in a subset of infant participants as per the national immunization schedule
Prevnar 20
Vaccine administered in a subset of infant participants as per the national immunization schedule
Infanrix
Vaccine administered in a subset of infant participants as per the national immunization schedule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.
* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.
* Capable of giving personal signed informed consent.
* Willing to give informed consent for her infant to participate in the study.
\- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian
Exclusion Criteria
* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.
* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.
* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.
* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).
\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.
\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.
Refer to the study contact for further eligibility details
1 Day
49 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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ClinMed
Phoenix, Arizona, United States
Genesis OB/GYN
Tucson, Arizona, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Antelope Valley Medical Center
Lancaster, California, United States
Chemidox Clinical Trials
Lancaster, California, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, United States
Mountain View Hospital
Idaho Falls, Idaho, United States
Madison Memorial Hospital
Rexburg, Idaho, United States
Velocity Clinical Research, Covington
Covington, Louisiana, United States
Boeson Research GTF
Great Falls, Montana, United States
Origin Health GTF
Great Falls, Montana, United States
Boeson Research MSO
Missoula, Montana, United States
Origin Health
Missoula, Montana, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Midwest Children's Health Research Center
Lincoln, Nebraska, United States
Midwest Children's Health Research Center
Lincoln, Nebraska, United States
Bryan Health
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Women's Health Care Center of Williamsburg
Lincoln, Nebraska, United States
Midwest Children's Health Research Center
Lincoln, Nebraska, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
Maximos Ob/Gyn
League City, Texas, United States
Sentara Leigh Hospital
Norfolk, Virginia, United States
The Group For Women - Kempsville Office
Norfolk, Virginia, United States
Tidewater Physicians for Women
Norfolk, Virginia, United States
Womens Care Center
Norfolk, Virginia, United States
Virginia Physicians For Women (VPFW)
North Chesterfield, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
St.Mary's Hospital
Kurume, Fukuoka, Japan
Sendai City Hospital
Sendai, Miyagi, Japan
Beppu Medical Center
Beppu-shi, Oita Prefecture, Japan
Osaka Habikino Medical Center
Habikino, Osaka, Japan
Taniguchi Hospital
Izumisano, Osaka, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Fukui Aiiku Hospital
Fukui, , Japan
Rakuwakai Otowa Hospital
Kyoto, , Japan
Shizuoka General Hospital
Shizuoka, , Japan
National Taiwan University Hospital
Taipei, , Taiwan
St. George's Hospital
London, England, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
The Princess Royal Hospital
Shropshire, Telford AND Wrekin, United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-503070-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C1091009
Identifier Type: -
Identifier Source: org_study_id