Status:
RECRUITING
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
1-49 years
Phase:
PHASE3
Brief 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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2029
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT07160244
Start Date
August 25 2025
End Date
March 2 2029
Last Update
December 17 2025
Active Locations (71)
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1
SEC Clinical Research
Dothan, Alabama, United States, 36305
2
ClinMed
Phoenix, Arizona, United States, 85004
3
Genesis OB/GYN
Tucson, Arizona, United States, 85741
4
Eclipse Clinical Research
Tucson, Arizona, United States, 85745