Trials / Completed
CompletedNCT05101486
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 755 (actual)
- Sponsor
- Janssen Vaccines & Prevention B.V. · Industry
- Sex
- All
- Age
- 60 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad26.RSV.PreF-based Vaccine | Ad26.RSV.PreF-based Vaccine will be administered as single IM injection. |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2022-03-28
- Completion
- 2022-09-20
- First posted
- 2021-11-01
- Last updated
- 2025-05-25
- Results posted
- 2023-09-06
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05101486. Inclusion in this directory is not an endorsement.