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BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
NCT07160244 · View on ClinicalTrials.gov ↗
Study Summary
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies. 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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Multivalent Group B streptococcus vaccine
- BIOLOGICAL Infanrix hexa
- BIOLOGICAL Prevenar 20
- BIOLOGICAL Pediarix
Study Locations (20)
Idaho
- Advanced Specialty Research — Boise
- Express Lab — Garden City
- Clinical Research Prime — Idaho Falls
- Eastern Idaho Regional Medical Center — Idaho Falls
- Mountain View Hospital — Idaho Falls
- Madison Memorial Hospital — Rexburg
Florida
- South Florida Clinical Research Institute - Margate — Margate
- Citadelle Clinical Research — North Miami Beach
- Emerald Coast OBGYN Clinical Research — Panama City
- HCA Florida Gulf Coast Hospital — Panama City
Arizona
- ClinMed — Phoenix
- Genesis OB/GYN — Tucson
- Eclipse Clinical Research — Tucson
Iowa
- Accellacare - McFarland — Ames
- Mary Greeley Medical Center — Ames
- McFarland Clinic, PC — Ames
California
- Antelope Valley Medical Center — Lancaster
- Chemidox Clinical Trials — Lancaster
Alabama
- SEC Clinical Research — Dothan
Louisiana
- Velocity Clinical Research, Covington — Covington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,000 participants |
| Start Date | 2025-08-25 |
| Est. Completion | 2029-03-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07160244
The ClinicalTrials.gov registry entry for NCT07160244 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07160244 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Idaho, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07160244 about?
NCT07160244 is a clinical study titled "BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies". BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies. This study is seeking healthy pregnant participants: * aged 49 or younger who can join. * b...
What is the current status of trial NCT07160244?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 6,000 participants. The study started on 2025-08-25. Estimated completion is 2029-03-02.
What conditions does trial NCT07160244 study?
This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07160244?
The interventions under investigation include: Placebo (BIOLOGICAL), Multivalent Group B streptococcus vaccine (BIOLOGICAL), Infanrix hexa (BIOLOGICAL), Prevenar 20 (BIOLOGICAL), Pediarix (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07160244?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07160244 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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