BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
Recruiting
Phase 3
Interventional Study
Healthy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 1 Day – 49
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 6,000 (estimated)
- Sponsor
- Pfizer · Industry
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About This Trial
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 al…
Trial Locations
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Eligibility Criteria
Key Inclusion criteria- Maternal:
* Healthy pregnant women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.
* Had a fetal anomaly ultrasound exa…
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