BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
← catalyst calendarNCT07160244 · readout in 810 d
Sponsored by Pfizer (industry) · PFE — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
6,000estimated
Sites
207
Countries
Argentina, Brazil, Canada +10
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-25 | actual | When the study began enrolling |
| Primary completion | 2028-11-06 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-03-02 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy
Interventions
- Biological: Multivalent Group B streptococcus vaccine — also filed as GBS6
- Biological: Placebo
- Biological: Infanrix hexa
- Biological: Prevenar 20
- Biological: Pediarix
- Biological: Prevnar 20
- Biological: Infanrix
Primary outcomes
what the primary-completion date above is the date OFThe proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention
measured Within 7 days
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention
measured Within 7 days
The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention
measured 1 month
The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery
measured 6 months after delivery
The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery
measured 6 months after delivery
The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery.
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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.
measured 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.
measured Birth
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