Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Prevention
Enrollment
240actual
Sites
6
Country
Australia
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 | 2025-07-14 | actual | When the study began enrolling |
| Primary completion | 2026-03-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-17 | actual | The whole study's end, after follow-up |
| First posted | 2025-07-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-28 | 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 Immunization
Interventions
- Biological: RSV vaccine formulation 1 dose
- Biological: RSV vaccine formulation 2 dose
- Biological: RSV vaccine formulation 3 dose
- Biological: RSV vaccine formulation 4 dose
- Biological: RSV vaccine formulation 5 dose
- Biological: RSV vaccine formulation 6 dose
- Biological: RSV vaccine formulation 7 dose
- Biological: RSV vaccine formulation 8 dose
Primary outcomes
what the primary-completion date above is the date OFPresence of any unsolicited systemic adverse events (aes)
measured Within 30 minutes after each vaccine injection
Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)
measured Through 7 days after each vaccine injection
Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)
measured Through 7 days after each vaccine injection
Presence of unsolicited AEs
measured Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)
measured Throughout study, approximately 6 months
Presence of out-of-range biological test results (including shift from baseline values)
measured Through 7 days after each vaccine injection
RSV A nAb (Neutralizing Antibodies) titers
measured At day 1 and day 29
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