Trials / Completed
CompletedNCT05083585
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
A Randomized, Double-blind Phase 3 Study to Compare the Immunogenicity of Clinical Trial Material of an Ad26.RSV.preF-based Vaccine for Phase 3 With Clinical Trial Material Representative of Phase 2b in Adults Aged 60 to 75 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Janssen Vaccines & Prevention B.V. · Industry
- Sex
- All
- Age
- 60 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad26.RSV.preF-based vaccine | Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection. |
Timeline
- Start date
- 2021-10-08
- Primary completion
- 2022-03-07
- Completion
- 2022-09-22
- First posted
- 2021-10-19
- Last updated
- 2025-05-25
- Results posted
- 2023-09-11
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05083585. Inclusion in this directory is not an endorsement.