drugset / Trial / NCT01475305
Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
RandomizedParallel-groupTriple-blindPrevention
Summary
The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.
Timeline
- Start
- 2011-10-20
- Primary completion
- 2011-12-03
- Completion
- 2012-12-13
Outcome
Missed primary endpoint
Stopped (Enrollment): “The study was terminated as it was determined to not be feasible to complete enrollment and the study within the required timeline and budget.”
registry NUMBER Placebo: 66.7 percentage of participants NCT01475305 ↗
registry NUMBER MEDI-557: 0.0 percentage of participants NCT01475305 ↗
registry Relative Risk 0.00 (95% CI 0.00 to 2.05) NCT01475305 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MEDI-557 | Monoclonal antibody | 30 mg/kg | Intravenous |