Trials / Completed
CompletedNCT02926430
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Janssen Vaccines & Prevention B.V. · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5\*10\^10 viral particles (vp) or 1\*10\^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad26.RSV.preF 5*10^10 vp | Ad26.RSV.preF will be given at a concentration of 5\*10\^10 vp/0.5 milliliter (mL). |
| BIOLOGICAL | Ad26.RSV.preF 1*10^11 vp | Ad26.RSV.preF will be given at a concentration of 1\*10\^11 vp/0.5 milliliter (mL). |
| DRUG | Placebo | Participants will receive placebo as formulation buffer. |
Timeline
- Start date
- 2016-11-08
- Primary completion
- 2018-03-14
- Completion
- 2019-01-29
- First posted
- 2016-10-06
- Last updated
- 2019-02-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02926430. Inclusion in this directory is not an endorsement.