Trials / Completed
CompletedNCT06237296
Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older
A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV/hMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 558 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older. Treatment: * RSV/hMPV mRNA / LNP 1 at 3-4 different doses or, * RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or, * RSV mRNA / LNP 1 at 1 dose or, * hMPV mRNA / LNP 1 at 1 dose
Detailed description
Study duration per participant is approximately 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSV/hMPV mRNA LNP 1 | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| BIOLOGICAL | RSV/hMPV mRNA LNP 2 | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| BIOLOGICAL | RSV mRNA LNP 1 | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
| BIOLOGICAL | hMPV mRNA LNP 1 | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection |
Timeline
- Start date
- 2024-01-23
- Primary completion
- 2025-02-11
- Completion
- 2025-02-11
- First posted
- 2024-02-01
- Last updated
- 2025-09-11
Locations
17 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06237296. Inclusion in this directory is not an endorsement.