Trials / Completed
CompletedNCT06134648
Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
A Phase I/IIa, Randomized, Observer-blind Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an RSV/hMPV Vaccine, in Adult Participants Aged 60 Years and Older
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 646 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
Detailed description
Study duration per participant: 12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort. Treatment Duration: Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination. Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination. Booster Cohort: 1 IM injection 12 months after the primary vaccination (Main Cohort). Participants will be followed for 12 months after administration of the booster dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSV/hMPV vaccine candidate Dose L | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| BIOLOGICAL | RSV/hMPV vaccine candidate Dose A | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| BIOLOGICAL | RSV/hMPV vaccine candidate Dose B | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| BIOLOGICAL | Placebo | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2026-02-27
- Completion
- 2026-02-27
- First posted
- 2023-11-18
- Last updated
- 2026-03-12
Locations
13 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06134648. Inclusion in this directory is not an endorsement.