NCT07160244From ClinicalTrials.govRecruiting

BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies

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

Healthy

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 6,000
Started: 25 August 2025
Main results due: 6 November 2028
Study sites: 216
Registry updated: 25 September 2026

Can you take part?

Ages 1 day to 49 years.
Open to any sex.
Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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 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.

Key Exclusion criteria- Maternal:

* Prepregnancy body mass index (BMI) of \>40 kg/m2.
* 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).

Key Inclusion criteria- Infant Participants

\- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian

Key Exclusion Criteria - Infant Participants:

\- 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.

Key Exclusion Criteria - Infant immunogenicity subset Participants:

\- 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(216)

Center for Research in Women's Health
Birmingham, Alabama, United States
Recruiting
Children's of Alabama
Birmingham, Alabama, United States
Recruiting
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
Recruiting
University of Alabama at Birmingham Women & Infants Center
Birmingham, Alabama, United States
Recruiting
SEC Clinical Research
Dothan, Alabama, United States
Recruiting
USA Health Allen Cox Building
Mobile, Alabama, United States
Recruiting
USA Health Children's and Women's Hospital
Mobile, Alabama, United States
Recruiting
USA Health Mitchell Cancer Institute
Mobile, Alabama, United States
Recruiting
USA Health Strada Patient Care Center
Mobile, Alabama, United States
Recruiting
ClinMed
Phoenix, Arizona, United States
Recruiting
Valleywise Comprehensive Health Center Women's Clinic
Phoenix, Arizona, United States
Recruiting
Valleywise Health Medical Center
Phoenix, Arizona, United States
Recruiting
Northwest Women's Center
Tucson, Arizona, United States
Recruiting
Genesis OB/GYN
Tucson, Arizona, United States
Recruiting
Eclipse Clinical Research
Tucson, Arizona, United States
Recruiting
Antelope Valley Medical Center
Lancaster, California, United States
Recruiting
Chemidox Clinical Trials
Lancaster, California, United States
Recruiting
Loma Linda University Children's Hospital
Loma Linda, California, United States
Recruiting
Loma Linda University Health System
Loma Linda, California, United States
Recruiting
Loma Linda University Pediatrics Clinic
Loma Linda, California, United States
Recruiting
Lucile Packard Children's Hospital
Palo Alto, California, United States
Recruiting
Stanford Obstetrics Clinic
Palo Alto, California, United States
Recruiting
Stanford University Medical Center
Palo Alto, California, United States
Recruiting
Stanford University
Palo Alto, California, United States
Recruiting
Anschutz Health Sciences Building
Aurora, Colorado, United States
Recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Recruiting
CU Research Pharmacy
Aurora, Colorado, United States
Recruiting
University of Colorado AO1
Aurora, Colorado, United States
Recruiting
University of Colorado Hospital Outpatient Pavilion
Aurora, Colorado, United States
Recruiting
University of Colorado Hospital
Aurora, Colorado, United States
Recruiting
University of Colorado Research II Building
Aurora, Colorado, United States
Recruiting
South Florida Clinical Research Institute - Margate
Margate, Florida, United States
Recruiting
Citadelle Clinical Research
North Miami Beach, Florida, United States
Recruiting
Emerald Coast OBGYN Clinical Research
Panama City, Florida, United States
Recruiting
Emerald Coast Pediatrics
Panama City, Florida, United States
Recruiting
HCA Florida Gulf Coast Hospital
Panama City, Florida, United States
Recruiting
ASR, LLC
Boise, Idaho, United States
Recruiting
Express Lab
Garden City, Idaho, United States
Recruiting
Clinical Research Prime
Idaho Falls, Idaho, United States
Recruiting
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, United States
Recruiting
Mountain View Hospital
Idaho Falls, Idaho, United States
Recruiting
Madison Memorial Hospital
Rexburg, Idaho, United States
Recruiting
Velocity Clinical Research, Covington
Covington, Louisiana, United States
Recruiting
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Recruiting
Center for Immunization Research
Baltimore, Maryland, United States
Recruiting
Center for Immunization Research
Baltimore, Maryland, United States
Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Recruiting
Gynecology and Obstetrics at Johns Hopkins Health Care and Surgery Center- White Marsh
Nottingham, Maryland, United States
Recruiting
Boston Medical Center
Boston, Massachusetts, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Active, not recruiting
Boeson Research GTF
Great Falls, Montana, United States
Recruiting
Great Falls OBGYN Associates
Great Falls, Montana, United States
Recruiting
Origin Health GTF
Great Falls, Montana, United States
Recruiting
Blue Moose Pediatrics
Missoula, Montana, United States
Recruiting
Boeson Research MSO
Missoula, Montana, United States
Recruiting
Origin Health
Missoula, Montana, United States
Recruiting
CHI Health St Francis
Grand Island, Nebraska, United States
Recruiting
Grand Island Regional Medical Center
Grand Island, Nebraska, United States
Recruiting
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Recruiting
Midwest Children's Health Research Center
Lincoln, Nebraska, United States
Recruiting

Showing 60 of 216 sites — filter to narrow it down. 211 of the 216 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07160244. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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