BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies (NCT07160244)
A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Center for Research in Women's Health — Birmingham, Alabama
Age range: 1 Day to 49 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (206 Sites)
Showing the first 25 of 206 sites.
- Center for Research in Women's Health — Birmingham, Alabama
- Children's of Alabama — Birmingham, Alabama
- University of Alabama at Birmingham - School of Medicine — Birmingham, Alabama
- University of Alabama at Birmingham Women & Infants Center — Birmingham, Alabama
- SEC Clinical Research — Dothan, Alabama
- USA Health Allen Cox Building — Mobile, Alabama
- USA Health Children's and Women's Hospital — Mobile, Alabama
- USA Health Mitchell Cancer Institute — Mobile, Alabama
- USA Health Strada Patient Care Center — Mobile, Alabama
- ClinMed — Phoenix, Arizona
- Valleywise Comprehensive Health Center Women's Clinic — Phoenix, Arizona
- Valleywise Health Medical Center — Phoenix, Arizona
- Genesis OB/GYN — Tucson, Arizona
- Eclipse Clinical Research — Tucson, Arizona
- Antelope Valley Medical Center — Lancaster, California
- Chemidox Clinical Trials — Lancaster, California
- Loma Linda University Children's Hospital — Loma Linda, California
- Loma Linda University Health System — Loma Linda, California
- Loma Linda University Pediatrics Clinic — Loma Linda, California
- Lucile Packard Children's Hospital — Palo Alto, California
- Stanford Obstetrics Clinic — Palo Alto, California
- Stanford University Medical Center — Palo Alto, California
- Stanford University — Palo Alto, California
- Anschutz Health Sciences Building — Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.