A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF
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Sponsored by Pfizer (industry) · PFE — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Prevention
Enrollment
540estimated
Sites
13
Country
India
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 | 2026-06-22 | actual | When the study began enrolling |
| Primary completion | 2027-01-25 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-25 | estimated | The whole study's end, after follow-up |
| First posted | 2026-06-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | 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)
Interventions
- Biological: RSVpreF
- Biological: Placebo
Primary outcomes
what the primary-completion date above is the date OFProportion of participants reporting local reactions within 7 days following investigational product administration
measured Within 7 days
Percentage of participants reporting systemic events within 7 days following investigational product administration
measured Within 7 days
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 3 months after vaccination
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
measured Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
measured Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as seroresponse rate
measured 1 month after vaccination
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