Trials / Active Not Recruiting
Active Not RecruitingNCT06604767
Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 390 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
Detailed description
The study duration will be up to approximately 12 months minus the screening period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | parainfluenza virus type 3 vaccine (PIV3) | Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular |
| BIOLOGICAL | RSV/hMPV/PIV3 vaccine | Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular |
| BIOLOGICAL | RSV/hMPV vaccine | Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular |
| BIOLOGICAL | RSV vaccine 1 | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular |
| BIOLOGICAL | RSV vaccine 2 | Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular |
Timeline
- Start date
- 2024-09-17
- Primary completion
- 2026-03-25
- Completion
- 2026-03-25
- First posted
- 2024-09-19
- Last updated
- 2026-01-22
Locations
8 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT06604767. Inclusion in this directory is not an endorsement.