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

Conditions

• Healthy

Eligibility Criteria

Sex

ALL

Age

1 Day - 49 Years

Healthy Volunteers

Accepted

Interventions

• Multivalent Group B streptococcus vaccine — BIOLOGICAL
  Multivalent Group B streptococcus vaccine
• Placebo — BIOLOGICAL
  Saline Control
• Infanrix hexa — BIOLOGICAL
  Vaccine administered in a subset of infant participants as per the national immunization schedule
• Prevenar 20 — BIOLOGICAL
  Vaccine administered in a subset of infant participants as per the national immunization schedule
• Pediarix — BIOLOGICAL
  Vaccine administered in a subset of infant participants as per the national immunization schedule
• Prevnar 20 — BIOLOGICAL
  Vaccine administered in a subset of infant participants as per the national immunization schedule
• Infanrix — BIOLOGICAL
  Vaccine administered in a subset of infant participants as per the national immunization schedule

Study Details

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.

Key Dates

Start date

Aug 25, 2025

Status verified

Jun 2026

Primary completion

Nov 6, 2028

Completion

Mar 2, 2029

Study Design

Enrollment

6,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: GBS6
  Multivalent group B streptococcus vaccine
• Placebo Comparator: Placebo
  Placebo
• Experimental: Infanrix hexa
  Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)
• Experimental: Prevenar 20
  Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
• Experimental: Pediarix
  Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio
• Experimental: Prevnar 20
  Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
• Experimental: Infanrix
  Commercially available combination vaccine containing diphtheria, tetanus, and pertussis

Primary Outcome Measure

The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention [ Time Frame: Within 7 days ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (114)

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