Trials / Completed
CompletedNCT05071313
A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 777 (actual)
- Sponsor
- Janssen Vaccines & Prevention B.V. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad26.RSV.preF-based vaccine | Ad26.RSV.preF-based vaccine will be administered as single IM injection. |
| BIOLOGICAL | Quadrivalent High-dose Influenza Vaccine | Quadrivalent High-dose Influenza Vaccine will be administered as IM injection. |
| BIOLOGICAL | Placebo | Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine. |
Timeline
- Start date
- 2021-10-04
- Primary completion
- 2022-04-20
- Completion
- 2022-10-11
- First posted
- 2021-10-08
- Last updated
- 2025-05-25
- Results posted
- 2023-09-13
Locations
19 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05071313. Inclusion in this directory is not an endorsement.