BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
- 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.
- Short title
- BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2029-03-02
- First posted
- 2025-09-08
- Registry last updated
- 2026-08-24
- Primary completion date
- 2028-11-06
- Start date
- 2025-08-25
- Participants
- 6,000
- Participant count basis
- Estimated
- Planned participants
- 6,000
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Pfizer
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07160244
- ClinicalTrials.gov ID
- NCT07160244
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention
Timeframe: Within 7 days
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention
Timeframe: Within 7 days
The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention
Timeframe: 1 month
The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery
Timeframe: 6 months after delivery
The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery
Timeframe: 6 months after delivery
The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery.
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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.
Timeframe: 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.
Timeframe: Birth
To measure GBS serotype-specific opsonophagocytic titers in infant participants at birth by geometric mean ratio between GBS6 group versus placebo group and by the difference in seroresponse rates between GBS6 group and placebo group
Timeframe: Birth
To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS disease (all disease) caused by the 6 individual vaccine serotypes in infants when GBS6 is administered to healthy pregnant women.
Timeframe: Birth
To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6.
Timeframe: Birth
To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS LOD and EOD, separately, caused by the 6 individual vaccine serotypes (Ia, Ib, II, III, IV, and V) in infants when GBS6 is administered to healthy pregnant women.
Timeframe: Birth
To measure GBS serotype-specific IgG by geometric mean concentration in maternal participants at 1 month after vaccination and at delivery.
Timeframe: 1 month after vaccination and at delivery
Compare the proportion of infants with anti-diphtheria toxoid and/or pneumococcal IgG responses at 1 month post-primary and toddler doses between GBS6 and placebo groups, including predefined IgG levels and geometric mean ratios.
Timeframe: 1 month after the primary vaccination series and 1 month after the toddler dose
- Sex
- All
- Age groups
- Children, Adults
- Minimum age
- 1 Day
- Maximum age
- 49 Years
- Healthy volunteers
- Yes
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
- Center for Research in Women's HealthBirmingham, United StatesRecruiting
- Children's of AlabamaBirmingham, United StatesRecruiting
- University of Alabama at Birmingham - School of MedicineBirmingham, United StatesRecruiting
- University of Alabama at Birmingham Women & Infants CenterBirmingham, United StatesRecruiting
- SEC Clinical ResearchDothan, United StatesRecruiting
- USA Health Allen Cox BuildingMobile, United StatesRecruiting
- USA Health Children's and Women's HospitalMobile, United StatesRecruiting
- USA Health Mitchell Cancer InstituteMobile, United StatesRecruiting
- USA Health Strada Patient Care CenterMobile, United StatesRecruiting
- ClinMedPhoenix, United StatesRecruiting
- Valleywise Comprehensive Health Center Women's ClinicPhoenix, United StatesRecruiting
- Valleywise Health Medical CenterPhoenix, United StatesRecruiting
- Genesis OB/GYNTucson, United StatesRecruiting
- Eclipse Clinical ResearchTucson, United StatesRecruiting
- Antelope Valley Medical CenterLancaster, United StatesRecruiting
- Chemidox Clinical TrialsLancaster, United StatesRecruiting
- Loma Linda University Children's HospitalLoma Linda, United StatesRecruiting
- Loma Linda University Health SystemLoma Linda, United StatesRecruiting
- Loma Linda University Pediatrics ClinicLoma Linda, United StatesRecruiting
- Lucile Packard Children's HospitalPalo Alto, United StatesRecruiting
- Stanford Obstetrics ClinicPalo Alto, United StatesRecruiting
- Stanford University Medical CenterPalo Alto, United StatesRecruiting
- Stanford UniversityPalo Alto, United StatesRecruiting
- Anschutz Health Sciences BuildingAurora, United StatesRecruiting
- Children's Hospital ColoradoAurora, United StatesRecruiting
And 181 more, listed on the interactive page.
- Related resource (pmiform.com)
Other registry identifiers
- 2022-503070-36-00
Related records
Drugs (3)
- Hydroxyurea
- Rotigaptide
- Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae CRM197