A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Infants

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 49
Healthy Volunteers: t
View:

• 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.

⁃ \- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian

Locations
United States
Arizona
Eclipse Clinical Research
NOT_YET_RECRUITING
Tucson
Genesis OB/GYN
NOT_YET_RECRUITING
Tucson
California
Chemidox Clinical Trials
NOT_YET_RECRUITING
Lancaster
Idaho
Clinical Research Prime
RECRUITING
Idaho Falls
Eastern Idaho Regional Medical Center
RECRUITING
Idaho Falls
Mountain View Hospital
RECRUITING
Idaho Falls
Madison Memorial Hospital
RECRUITING
Rexburg
Louisiana
Velocity Clinical Research, Covington
NOT_YET_RECRUITING
Covington
Montana
Boeson Research GTF
NOT_YET_RECRUITING
Great Falls
Great Falls OBGYN Associates
NOT_YET_RECRUITING
Great Falls
Boeson Research MSO
RECRUITING
Missoula
Origin Health
RECRUITING
Missoula
Nebraska
Velocity Clinical Research, Grand Island
RECRUITING
Grand Island
Velocity Clinical Research, Norfolk
RECRUITING
Norfolk
Virginia
Virginia Physicians For Women (VPFW)
RECRUITING
North Chesterfield
Clinical Research Partners, LLC
RECRUITING
Richmond
Other Locations
Japan
Fukui Aiiku Hospital
NOT_YET_RECRUITING
Fukui
Osaka Habikino Medical Center
NOT_YET_RECRUITING
Habikino
Taniguchi Hospital
NOT_YET_RECRUITING
Izumisano
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2029-03-02
Participants
Target number of participants: 6000
Treatments
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
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov