A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 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 · Quadruple · Prevention
Enrollment
270actual
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 | 2025-03-19 | actual | When the study began enrolling |
| Primary completion | 2025-12-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-11 | actual | The whole study's end, after follow-up |
| First posted | 2025-02-27 | 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
- Healthy Volunteers
- Influenza Vaccination
- Respiratory Syncytial Virus Vaccination
- Parainfluenza Vaccination
- Human Metapneumovirus Vaccination
Interventions
- Biological: TIV-HA Vaccine formulation 1 at low dose
- Biological: TIV-HA formulation 1 at high dose
- Biological: TIV-HA formulation 2 at low dose
- Biological: TIV-HA formulation 2 at high dose
- Biological: RSV/hMPV/PIV3 formulation 2 at low dose
- Biological: RSV/hMPV/PIV3 formulation 1 at high dose
- Biological: RSV/hMPV/PIV3 formulation 2 at high dose
- Biological: RSV/hMPV/PIV3 formulation 1 at low dose
- Biological: RIV4 (Supemtek®)
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 Within 30 minutes after each vaccination
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
measured Through 7 days after each vaccination
Presence of unsolicited AEs reported through 28 days after vaccination
measured Through 28 days after each vaccination
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
measured Throughout study, approximately 6 months
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
measured Through 7 days after vaccination
Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
measured Day 1 and Day 29
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
measured Day 1 and Day 29
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