RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
NCT02873286 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2020-09-22
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
- Respiratory Syncytial Virus Infections
Interventions
- BIOLOGICAL
-
MVA-BN-RSV
MVA-mBN294B
- OTHER
-
Placebo
Tris Buffered Saline, sterile
Sponsors & Collaborators
-
Bavarian Nordic
lead INDUSTRY
Principal Investigators
-
Steven Lawrence, MD · Washington University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- United States
Study Locations
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