Recruiting

Phase 3

GBS6BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies

Sponsor:

Pfizer

Code:

NCT07160244

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 0 - 49

Healthy Volunteers: Accepted

Interventions

Multivalent Group B streptococcus vaccine

Placebo

Infanrix hexa

Prevenar 20

Pediarix

Study Details

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 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.

Conditions

Healthy

Study ID

NCT07160244

Start date

Aug 25, 2025

Status verified date

Aug, 2026

Completion date

Mar 2, 2029

Anticipated

Primary completion date

Nov 6, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 49

Healthy Volunteers: Accepted

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

Study Design

Enrollment

6000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Multivalent Group B streptococcus vaccine

Placebo

Saline Control

Infanrix hexa

Vaccine administered in a subset of infant participants as per the national immunization schedule

Prevenar 20

Vaccine administered in a subset of infant participants as per the national immunization schedule

Pediarix

Vaccine administered in a subset of infant participants as per the national immunization schedule

Prevnar 20

Vaccine administered in a subset of infant participants as per the national immunization schedule

Infanrix

Vaccine administered in a subset of infant participants as per the national immunization schedule

Primary outcome measure

The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention [ Time Frame: Within 7 days ]
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention [ Time Frame: Within 7 days ]
The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention [ Time Frame: 1 month ]
The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery [ Time Frame: 6 months after delivery ]
The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery [ Time Frame: 6 months after delivery ]
The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery. [ Time Frame: 6 months after delivery ]
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events (AEs) from birth through 1 month of age [ Time Frame: Birth to 1 month of age ]
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting serious adverse events (SAEs) from birth through end of the study [ Time Frame: Through study completion, at least 1 year ]
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting medically attended adverse events (MAAEs) from birth through 6 months of age [ Time Frame: Birth to 6 months of age ]
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events of special interest (AESIs) from birth through end of study [ Time Frame: Through study completion, at least 1 year ]
To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS late onset disease thresholds in the GBS6 group to the placebo group [ Time Frame: Birth ]
To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS early onset disease thresholds in the GBS6 group to the placebo group [ Time Frame: Birth ]
To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS late onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. [ Time Frame: Birth ]
To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS early onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. [ Time Frame: Birth ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Center for Research in Women's Health

Recruiting

Birmingham, Alabama, United States, 35233

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

University of Alabama at Birmingham - School of Medicine

Recruiting

Birmingham, Alabama, United States, 35233

University of Alabama at Birmingham Women & Infants Center

Recruiting

Birmingham, Alabama, United States, 35294

SEC Clinical Research

Recruiting

Dothan, Alabama, United States, 36305

USA Health Allen Cox Building

Recruiting

Mobile, Alabama, United States, 36604

USA Health Children's and Women's Hospital

Recruiting

Mobile, Alabama, United States, 36604

USA Health Mitchell Cancer Institute

Recruiting

Mobile, Alabama, United States, 36604

USA Health Strada Patient Care Center

Recruiting

Mobile, Alabama, United States, 36604

ClinMed

Recruiting

Phoenix, Arizona, United States, 85004

Valleywise Comprehensive Health Center Women's Clinic

Recruiting

Phoenix, Arizona, United States, 85008

Valleywise Health Medical Center

Recruiting

Phoenix, Arizona, United States, 85008

Genesis OB/GYN

Recruiting

Tucson, Arizona, United States, 85741

Eclipse Clinical Research

Recruiting

Tucson, Arizona, United States, 85745

Antelope Valley Medical Center

Recruiting

Lancaster, California, United States, 93534

Chemidox Clinical Trials

Recruiting

Lancaster, California, United States, 93534

Loma Linda University Children's Hospital

Recruiting

Loma Linda, California, United States, 92354

Loma Linda University Health System

Recruiting

Loma Linda, California, United States, 92354

Loma Linda University Pediatrics Clinic

Recruiting

Loma Linda, California, United States, 92354

Lucile Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94304

Stanford Obstetrics Clinic

Recruiting

Palo Alto, California, United States, 94304

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Anschutz Health Sciences Building

Recruiting