BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT07160244
- Run by
- Pfizer
- People needed
- 6000
- Starts
- 2025-08-25
- Expected to finish
- 2029-03-02
- Last updated by the study team
- 2026-07-09
Who can join
Age: 0 and older, up to 49. Sex: any. Healthy volunteers: accepted.
Where it is running
- Children's of Alabama — Birmingham, Alabama, United States (enrolling)
- University of Alabama at Birmingham - School of Medicine — Birmingham, Alabama, United States (enrolling)
- University of Alabama at Birmingham Women & Infants Center — Birmingham, Alabama, United States (enrolling)
- SEC Clinical Research — Dothan, Alabama, United States (enrolling)
- USA Health Allen Cox Building — Mobile, Alabama, United States (enrolling)
- USA Health Children's and Women's Hospital — Mobile, Alabama, United States (enrolling)
- USA Health Mitchell Cancer Institute — Mobile, Alabama, United States (enrolling)
- USA Health Strada Patient Care Center — Mobile, Alabama, United States (enrolling)
- ClinMed — Phoenix, Arizona, United States (enrolling)
- Valleywise Comprehensive Health Center Women's Clinic — Phoenix, Arizona, United States (enrolling)
- Valleywise Health Medical Center — Phoenix, Arizona, United States (enrolling)
- Genesis OB/GYN — Tucson, Arizona, United States (enrolling)
- Eclipse Clinical Research — Tucson, Arizona, United States (enrolling)
- Antelope Valley Medical Center — Lancaster, California, United States (enrolling)
- Chemidox Clinical Trials — Lancaster, California, United States (enrolling)
- Loma Linda University Children's Hospital — Loma Linda, California, United States (enrolling)
- Loma Linda University Health System — Loma Linda, California, United States (enrolling)
- Loma Linda University Pediatrics Clinic — Loma Linda, California, United States (enrolling)
- Lucile Packard Children's Hospital — Palo Alto, California, United States (enrolling)
- Stanford Obstetrics Clinic — Palo Alto, California, United States (enrolling)
- Stanford University Medical Center — Palo Alto, California, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- Anschutz Health Sciences Building — Aurora, Colorado, United States (enrolling)
- Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
- Center for Research in Women's Health — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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