Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age
← catalyst calendarNCT07516418 · readout in 228 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Prevention
Enrollment
570estimated
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 | 2026-04-15 | actual | When the study began enrolling |
| Primary completion | 2027-04-04 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-04-04 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-08 | 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 (RSV)
- Influenza A(H5N1)
Interventions
- Biological: H5 Flu Investigational Medical Product (IMP) 1
- Biological: H5 Flu IMP 2
- Biological: H5 Flu IMP 3
- Biological: RSV IMP 4
- Biological: RSV IMP 5
- Biological: RSV IMP 6
- Biological: H5 Flu IMP 7
- Biological: H5 Flu IMP 8
- Biological: H5 Flu IMP 9
- Biological: H5 Flu IMP 10
- Biological: H5 Flu IMP 11
- Biological: H5 Flu IMP 12
Primary outcomes
what the primary-completion date above is the date OFPresence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
measured On Day 1
Presence of solicited injection site reactions (ie, injection site pain, injection site erythema, injection site swelling, pre-listed in participant's diary and in the eCRF (electronic case report form)) occurring through 7 days after each vaccination
measured Day 1 through day 8
Presence of solicited systemic reactions (ie, fever, headache, and only new or worsened fatigue, myalgia, arthralgia, and chills pre-listed in the participant's diary and in the eCRF) occurring through 7 days after each vaccination
measured Day 1 through day 8
Presence of unsolicited AEs reported through 20 days after the first vaccination and after the second vaccination for IMPs with the Flu H5 antigen
measured Day 1 through day 21
Presence of unsolicited AEs reported through 28 days after vaccination for IMPs with the RSV antigen
measured Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination)
measured SAE: Screening day through day 202 (IMPs containing Flu H5 antigen), Screening day through day 181 (IMPs containing RSV antigen); AESI: Day 1 through day 202 (IMPs containing Flu H5 antigen), Day 1 through day 181 (IMPs containing RSV antigen)
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after each vaccination
measured Screening through day 8
Presence of AEs leading to study discontinuation throughout the study (ie, through 6 months after vaccination)
measured Screening through day 202 (IMPs containing Flu H5 antigen), Screening through day 181 (IMPs containing RSV antigen)
RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants receiving IMPs with the RSV antigen
measured Day 1 and day 29
Flu H5 antibody (Ab) titer measured by hemagglutination inhibition (HAI) at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen
measured Day 1, day 22 and day 43
Hemagglutination Inhibition (HAI) geometric mean titer ratio at 21 and 42 days post-vaccination relative to pre-vaccination for all participants receiving IMPs with the Flu H5 antigen
measured Day 1, day 22 and day 43
Seroconversion rate based on Hemagglutination inhibition (HAI) antibody titers at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen
measured Day 1, day 22 and day 43
Proportion of participants with Hemagglutination Inhibition (HAI) antibody titer ≥40 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen
measured Day 1, day 22, and day 43
Proportion of participants with detectable HAI antibody titer ≥10 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen
measured Day 1, day 22, and day 43
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