Trials / Completed
CompletedNCT02873286
RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
A Randomized, Single-blind, Placebo Controlled, Dose-ranging Phase II Trial in ≥ 55 Year Old Adults to Evaluate the Safety and Immunogenicity of the Recombinant MVA-BN-RSV Vaccine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 420 (actual)
- Sponsor
- Bavarian Nordic · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Accepted
Summary
A total of 400 subjects will be recruited into five treatment subject groups à 80 subjects.Subject will receive two administrations 4 weeks apart which will consist of MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS). 86 subjects from 2 treatment groups (43 per treatment group) are supposed to receive one (booster) dose of MVA-BN-RSV vaccine approximately one year after their first vaccination. In this booster substudy, eligible subjects will receive the same dose they received during the main trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MVA-BN-RSV | MVA-mBN294B |
| OTHER | Placebo | Tris Buffered Saline, sterile |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2016-08-19
- Last updated
- 2020-09-22
- Results posted
- 2020-09-22
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02873286. Inclusion in this directory is not an endorsement.