A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.
← catalyst calendarNCT07543380 · readout in 12 d
Sponsored by Pfizer (industry) · PFE — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Prevention
Enrollment
130estimated
Sites
5
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 | 2026-05-11 | actual | When the study began enrolling |
| Primary completion | 2026-08-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-08-31 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Respiratory Syncytial Virus (RSV)
Intervention
- Biological: RSVpreF
Primary outcomes
what the primary-completion date above is the date OFPercentage of participants reporting prompted local reactions within 7 days following investigational product administration
measured Day 7
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
measured Day 7
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
measured 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) throughout the study
measured 2 months after vaccination
Geometric Mean Titer (GMT) ratio (GMR) , estimated by the ratio of the GMTs for RSV subgroup A (RSV A) and RSV subgroup B (RSV B) neutralizing titers (NTs) with RSVpreF in this study's participants to that in Study C3671013 Japanese older adults
measured 1 month after vaccination
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