SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS
← catalyst calendarSponsored by Pfizer (industry) · PFE — their whole pipeline →.
Phase
—
Status
Completed
Study type
Observational
Enrollment
497actual
Sites
1
Country
Japan
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 | 2024-10-01 | actual | When the study began enrolling |
| Primary completion | 2026-02-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-27 | actual | The whole study's end, after follow-up |
| First posted | 2024-07-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Respiratory Tract Infection
Intervention
- Biological: RSVpreF vaccine — also filed as Abrysvo
Primary outcomes
what the primary-completion date above is the date OFPercentage of pregnant women reporting Adverse Reactions for 28 days after vaccination
measured up to 28 days after vaccination
Percentage of pregnant women reporting Serious Adverse Reactions from the day of vaccination up to 28 days after delivery
measured up to 28 days after delivery
Percentage of pregnant women reporting reactogenicity events (local reactions and systemic events) from day of vaccination up to 7 days after vaccination
measured up to 7 days after vaccination
Percentage of infants reporting Adverse Reactions from the birthday up to 28 days after birth
measured up to 28 days after birth
Percentage of infants reporting Serious Adverse Reactions from the birthday up to 28 days after birth
measured up to 28 days after birth
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