Study to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older
← catalyst calendarNCT06907511 · readout in 104 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
720actual
Sites
13
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 | 2025-04-17 | actual | When the study began enrolling |
| Primary completion | 2026-12-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-01 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pandemic Influenza Immunization
- Healthy Volunteers
Interventions
- Biological: Pandemic flu H5 HA mRNA SD2 vaccine
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFPresence of immediate adverse events (AEs)
measured Within 30 minutes after each/any injection
Presence of solicited injection site reactions
measured Through 7 days after each/any injection
Presence of solicited systemic reactions
measured Through 7 days after each/any injection
Presence of unsolicited AEs
measured Through 21 days after the first injection through 28 days after the second injection
Presence of medically attended adverse events (MAAEs)
measured Through 180 days after the last injection
Presence of adverse events of special interest (AESIs)
measured Throughout the study, approximately 13 months
Presence of serious adverse events (SAEs)
measured Throughout the study, approximately 13 months
Presence of out-of-range biological test results (including shift from baseline values)
measured Through a maximum of 8 days after each injection
Permalink · SNY's whole pipeline · Catalyst calendar · Every registered study · What changed