NCT07516418 Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age
| NCT ID | NCT07516418 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sanofi |
| Condition | Respiratory Syncytial Virus (RSV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 570 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2027-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 570 participants in total. It began in 2026-04-15 with a primary completion date of 2027-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years. The total duration of study participation for each participant varies by stage and treatment arm. Stage 1: * For Arm 1, Arm 2, and Arm 3 the duration of study participation will be approximately 7 months for each participant. * For Arm 4, Arm 5, and Arm 6 the duration of study participation will be approximately 6 months for each participant. Stage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.
Eligibility 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.
Contact & Investigator
Sanofi Trial Transparency Email Recommended (Toll free for US and Canada)
✉ contact-us@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT07516418 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 49 Years, studying Respiratory Syncytial Virus (RSV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07516418 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07516418 currently recruiting?
Yes, NCT07516418 is actively recruiting participants. Contact the research team at contact-us@sanofi.com for enrollment information.
Where is the NCT07516418 trial being conducted?
This trial is being conducted at Griffith, Australia, Herston, Australia, Morayfield, Australia, Sippy Downs, Australia and 2 additional locations.
Who is sponsoring the NCT07516418 clinical trial?
NCT07516418 is sponsored by Sanofi. The trial plans to enroll 570 participants.