Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and High-Dose Inactivated Influenza Vaccine in Adult Participants 50 Years of Age and Older
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
980actual
Sites
12
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 | 2024-11-19 | actual | When the study began enrolling |
| Primary completion | 2026-04-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-16 | actual | The whole study's end, after follow-up |
| First posted | 2024-11-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- COVID-19 Immunization
- Influenza Immunization
Interventions
- Biological: IIV-HD
- Biological: rC19 (dose 1)
- Biological: IIV-HD + rC19 (dose 1)
- Biological: IIV-HD + rC19 (dose 2)
- Biological: IIV-HD + rC19 (dose 3)
- Biological: IIV-HD + rC19 (dose 4)
- Other: Placebo (0.9% NaCl)
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 with solicited injection site reactions
measured Up to 7 each days after vaccination
Number of participants with solicited systemic reactions
measured Up to 7 days after each vaccination
Number of participants with unsolicited AEs
measured Up to 28 days after each vaccination
Number of participants with adverse events of special interest (AESIs)
measured Up to 180 days after each vaccination
Number of participants with medical attended adverse events (MAAEs)
measured Up to 180 days after each vaccination
Number of MAAEs relating to predefined potential immune-mediated disease (PIMDs)
measured From D182 through 12 months following the last study vaccination
Number of participants with serious adverse events (SAEs)
measured Up to 180 days after each vaccination
Number of participants with related SAEs
measured From D182 through 12 months following the last study vaccination
Number of MAAEs relating to predefined PIMDs that meet the criteria for SAEs
measured From D182 through 12 months following the last study vaccination
Geometric mean (GM) of HAI titers in all participants
measured At D01 and D30
Geometric mean ratio (GMR) HAI titers ratio D30/D01 in all participants
measured At D01 and D30
GM of SARS-CoV-2 neutralizing titers in all participants
measured At D01 and D30
GMR of SARS-CoV-2 neutralizing titers ratio D30/D01 in all participants
measured At D01 and D30
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