At a glance
ClinicalIndex Comparison Record- ✓Age ≥55 years
- ✓No active cardiopulmonary or metabolic disease symptoms; stable on treatment ≥1 month is acceptable
- ✓If diabetic, HbA1c ≤8% within 3 months or confirmed controlled blood glucose at screening
- ✓BMI ≥18.5 and ≤39.9
- ✕Pregnant or breast-feeding women
- ✕Uncontrolled serious infection not responding to antimicrobial therapy
- ✕History of cerebrovascular disorder or stroke (TIA ≥1 year prior allowed)
- ✕Myocardial infarction within ≤1 year, angina pectoris, congestive heart failure ≥NYHA Grade II, or uncontrolled hypertension (SBP ≥150 or DBP ≥100 mmHg within last 2 months)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating MVA-BN-RSV and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 420 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
MVA-mBN294B
Tris Buffered Saline, sterile