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

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