Different vaccine formulations for RSV or H5 flu in adults 18–49
Official title: A Phase 1, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Healthy Participants 18 to 49 Years of Age
Run by Sanofi · NCT07516418 · Data updated 2026-11-12
This trial will try several vaccine formulations that produce either the RSV antigen or the H5 flu antigen in healthy adults 18 to 49 to see if they are safe and trigger immune responses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Enrollment | 570 (estimated) |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 6 sites (Griffith, Queensland and 5 other locations) |
| Status | Recruiting |
| Started | April 15, 2026 |
| Main results expected | April 4, 2027 |
| Study ends | April 4, 2027 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT07516418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18 to 49 who are not pregnant or breastfeeding and who meet contraception requirements if of child-bearing potential are eligible.
✕Probably not a fit
People outside the 18–49 age range, pregnant or breastfeeding individuals, and those with conditions that interfere with study evaluations (including many immunocompromised patients) are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, interventional trial enrolling healthy adults aged 18 to 49 to receive one of several investigational vaccine formulations encoding either an RSV monovalent antigen or the influenza H5 hemagglutinin antigen. Participants are assigned to arms across two stages and followed for approximately 6–7 months depending on their arm to monitor safety and immune responses. The study collects safety data and measures immunogenicity, primarily antibody responses, after vaccination. Multiple investigational product formulations are compared to identify tolerable formulations that elicit biologically meaningful immune signals.
Why it matters
Potential benefit: If successful, the tested formulations could identify safe vaccine candidates that induce protective immune responses against RSV or H5 influenza in adults.
How similar studies have gone: Early-phase vaccine studies for RSV and H5 influenza have previously produced measurable immune responses in adults, but broadly protective, widely licensed vaccines for these targets remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 to 49 years on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies: * Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR * Is of CBP (Child-Bearing Potential) and uses an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after the last study intervention administration. Exclusion Criteria: • Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it's running
-
Site # 0361002
Griffith, Queensland, Australia Recruiting -
Site # 0361001
Herston, Queensland, Australia Recruiting -
Site # 0361003
Morayfield, Queensland, Australia Recruiting -
Site # 0361005
Sippy Downs, Queensland, Australia Recruiting -
Site # 03610004
South Brisbane, Queensland, Australia Recruiting -
Site # 036006
Taringa, Queensland, Australia Recruiting
Study contacts
- Study coordinator: Sanofi Trial Transparency Email Recommended (Toll free for US and Canada)
- Email: contact-us@sanofi.com
- Phone: 800-633-1610
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.