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

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 1 Day and 49 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GBS6 		Multivalent group B streptococcus vaccine
  • Biological: Multivalent Group B streptococcus vaccine
    Multivalent Group B streptococcus vaccine
    Other names:
    • GBS6
Placebo Comparator
Placebo 		Placebo
  • Biological: Placebo
    Saline Control
Experimental
Infanrix hexa 		Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)
  • Biological: Infanrix hexa
    Vaccine administered in a subset of infant participants as per the national immunization schedule
Experimental
Prevenar 20 		Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
  • Biological: Prevenar 20
    Vaccine administered in a subset of infant participants as per the national immunization schedule
Experimental
Pediarix 		Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio
  • Biological: Pediarix
    Vaccine administered in a subset of infant participants as per the national immunization schedule
Experimental
Prevnar 20 		Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
  • Biological: Prevnar 20
    Vaccine administered in a subset of infant participants as per the national immunization schedule
Experimental
Infanrix 		Commercially available combination vaccine containing diphtheria, tetanus, and pertussis
  • Biological: Infanrix hexa
    Vaccine administered in a subset of infant participants as per the national immunization schedule
  • Biological: Infanrix
    Vaccine administered in a subset of infant participants as per the national immunization schedule

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com