Trials / Not Yet Recruiting
Not Yet RecruitingNCT07516418
Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | H5 Flu Investigational Medical Product (IMP) 1 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | H5 Flu IMP 2 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | H5 Flu IMP 3 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | RSV IMP 4 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | RSV IMP 5 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | RSV IMP 6 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | H5 Flu IMP 7 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | H5 Flu IMP 8 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | H5 Flu IMP 9 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | H5 Flu IMP 10 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | H5 Flu IMP 11 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| BIOLOGICAL | H5 Flu IMP 12 | Suspension for injection. Route of administration: Intramuscular (IM) injection |
Timeline
- Start date
- 2026-04-13
- Primary completion
- 2027-04-04
- Completion
- 2027-04-04
- First posted
- 2026-04-08
- Last updated
- 2026-04-08
Source: ClinicalTrials.gov record NCT07516418. Inclusion in this directory is not an endorsement.