Trials / Completed
CompletedNCT04354480
A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Single Vaccination of an Ad26.RSV.preF-based Regimen in Japanese Adults Aged 60 Years and Older
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Janssen Pharmaceutical K.K. · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
Summary
The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSV Vaccine | Participants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1. |
| OTHER | Placebo | Participants will receive a single IM injection of matching placebo on Day 1. |
Timeline
- Start date
- 2020-05-15
- Primary completion
- 2021-01-20
- Completion
- 2021-01-20
- First posted
- 2020-04-21
- Last updated
- 2025-02-03
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04354480. Inclusion in this directory is not an endorsement.