Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
← catalyst calendarNCT07734649 · readout in 623 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Prevention
Enrollment
2,400estimated
Sites
17
Country
United States
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 | 2026-07-22 | actual | When the study began enrolling |
| Primary completion | 2028-05-03 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-05-03 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Respiratory Syncytial Virus Immunization
- Human Metapneumovirus Immunization
- Healthy Volunteers
Interventions
- Biological: RSV+HMPV vaccine
- Biological: Control Vaccine 3
- Biological: Control Vaccine 4
- Biological: Control Vaccine 2
- Other: Placebo
- Biological: Control Vaccine 1
Primary outcomes
what the primary-completion date above is the date OFRSV A serum nAb (neutralizing antibodies) titers
measured At Day 1 and Day 29
RSV B serum nAb titers
measured At Day 1 and Day 29
HMPV A serum nAb titers
measured At Day 1 and Day 29
HMPV B serum nAb titers
measured At Day 1 and Day 29
Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination
measured Within 30 minutes after vaccination
Presence of solicited injection site and systemic reactions
measured For 8 days, including the day of vaccination
Presence of Unsolicited AEs
measured For 28 days, including day of vaccination
Presence of medically attended AEs (MAAEs)
measured Within 6 months after vaccination
Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs)
measured Throughout the study (approximately 12 months)
Presence of out-of-range biological test results
measured At Day 09
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