Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
← catalyst calendarNCT07779408 · readout in 549 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1/2
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · Double · Prevention
Enrollment
640estimated
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 2026-08-21
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-08-10 | estimated | When the study began enrolling |
| Primary completion | 2028-02-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-02-22 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Healthy Volunteers
- Influenza
Interventions
- Biological: Flu H5 egg pandemic low dose vaccine, with adjuvant
- Biological: Flu H5 Egg Pandemic medium dose vaccine, with adjuvant
- Biological: Flu H5 Egg Pandemic high dose vaccine, with adjuvant
- Biological: Flu H5 Egg Pandemic high dose vaccine, without adjuvant
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with immediate Adverse Events (AEs)
measured Within 30 minutes after each vaccination
Number of participants experiencing solicited administration site reactions (pre-listed in the participant diary and case report form [CRF])
measured Within 8 days of each vaccination, including the day of vaccination
Number of participants experiencing solicited systemic reactions (pre-listed in the participant diary and CRF)
measured Within 8 days of each vaccination, including the day of vaccination
Number of participants experiencing unsolicited AEs
measured Within 21 days after the first vaccination, including the day of the first vaccination, and within 28 days after the second vaccination, including the day of the second vaccination
Number of participants experiencing Medically Attended Adverse Events (MAAEs)
measured From Day 01 until the end of the study, approximately 14 months
Number of participants experiencing Adverse Events of Special Interest (AESIs)
measured From Day 01 until the end of the study, approximately 14 months
Number of participants experiencing Serious Adverse Events (SAEs)
measured From Day 01 until the end of the study, approximately 14 months
Number of participants experiencing out-of-range biological test results (including shift from baseline values)
measured Up to 8 days after each vaccination
Number of participants experiencing AEs leading to discontinuation
measured From Day 01 until the end of the study, approximately 14 months
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer
measured Day 01 and Day 43
Number of participants with HAI Ab titer ≥ 40 (1 dilution [dil]; ie, seroprotection)
measured Day 43
Number of participants with seroconversion
measured Day 01 and Day 43
Geometric mean titer ratio of individual HAI Ab titer ratio Day 43/Day 01
measured Day 01 and Day 43
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