BEATRIX: group B streptococcus (GBS) vaccine for pregnant women and their babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BEATRIX is a randomized, placebo-controlled Phase 3 study giving one dose of a 6‑valent GBS polysaccharide‑conjugate vaccine or saline to healthy pregnant women between 24 0/7 and 36 0/7 weeks of gestation. Participants must have a singleton pregnancy with a normal fetal anatomy ultrasound and documented negative HIV, syphilis, and hepatitis B tests. Mothers and infants are followed through delivery and for up to six months after birth to collect safety data and measure maternal and infant immune responses; infants will receive routine pediatric vaccines such as Infanrix hexa, Prevenar 20, or Pediarix as indicated. Key exclusions include high BMI (>40 kg/m2), current or prior pregnancy complications that raise risk, multiple gestation, or significant fetal anomalies.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

+169 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.