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NCT07160244 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Healthy, sponsored by Pfizer.

Recruiting
Registry status
Phase 3
Development phase
6,000
Enrollment target
20
Study locations

NCT07160244 is a Phase 3 study of Healthy that is actively recruiting participants, run by Pfizer. The registered enrollment target is 6,000 participants, above the 642-participant average among 1,090 other Healthy trials with a reported enrollment target (835% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT07160244, a Phase 3 study of Healthy, is actively recruiting participants, sponsored by Pfizer.

RECRUITING
Registry status
Phase 3
Development phase
6,000 participants
Enrollment target
20
Study locations

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

Healthy

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

FieldValue
Enrollment Target 6,000 participants
Start Date 2025-08-25
Est. Completion 2029-03-02
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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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, categorized as Phase 3. The registered enrollment target is 6,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 642-participant average among 1,090 other Healthy trials with a reported enrollment target (835% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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.

NCT07160244 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Idaho, Florida, Arizona.

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.

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).

Who is sponsoring clinical trial NCT07160244?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

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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