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Multivalent Group B streptococcus vaccine

Phase 3

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 29, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment6,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07160244BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their BabiesPHASE3 RECRUITING 6,000 — — Aug 25, 2025Mar 2, 2029May 29, 2026179 United States, Argentina +11
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Study Endpoints
Primary Endpoints
The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention
Within 7 days
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention
Within 7 days
The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention
1 month
The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery
6 months after delivery
The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery
6 months after delivery
The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery.
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
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
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
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
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
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
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.
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.
Birth
Secondary Endpoints
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
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.
Birth
To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6.
Birth
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
GBS6EXPERIMENTALMultivalent group B streptococcus vaccine
PlaceboPLACEBO_COMPARATORPlacebo
Infanrix hexaEXPERIMENTALCommercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)
Prevenar 20EXPERIMENTALCommercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
PediarixEXPERIMENTALCommercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio
Prevnar 20EXPERIMENTALCommercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
InfanrixEXPERIMENTALCommercially available combination vaccine containing diphtheria, tetanus, and pertussis
Interventions
NameTypeDescription
Multivalent Group B streptococcus vaccineBIOLOGICALMultivalent Group B streptococcus vaccine
PlaceboBIOLOGICALSaline Control
Infanrix hexaBIOLOGICALVaccine administered in a subset of infant participants as per the national immunization schedule
Prevenar 20BIOLOGICALVaccine administered in a subset of infant participants as per the national immunization schedule
PediarixBIOLOGICALVaccine administered in a subset of infant participants as per the national immunization schedule
Prevnar 20BIOLOGICALVaccine administered in a subset of infant participants as per the national immunization schedule
InfanrixBIOLOGICALVaccine administered in a subset of infant participants as per the national immunization schedule
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Eligibility Criteria
Age Range1 Day — 49 Years
SexALL
Healthy VolunteersYes
Study Sites179

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 exa...

Countries:United StatesArgentinaBrazilCanadaFinlandJapanMexicoNetherlandsSouth AfricaSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07160244lastUpdatePostDate: changed
LOWMay 29, 2026NCT07160244lastUpdatePostDate: changed
LOWMay 29, 2026NCT07160244lastUpdatePostDate: changed
LOWMay 26, 2026NCT07160244primaryCompletionDate: changed
LOWMay 24, 2026NCT07160244studyFirstPostDate: changed