Clinical trial
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically…
NCT03959488 · AstraZeneca, Industry · Completed
Key facts
| NCT number | NCT03959488 |
|---|---|
| Title | A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children |
| Official title | A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY) |
| Lead sponsor | AstraZeneca, Industry |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Respiratory Syncytial Virus Infections |
| Intervention type | Drug |
| Interventions | MEDI8897, Palivizumab |
| Enrollment | 925 |
| Start date | Jul 30, 2019 |
| Primary completion | May 3, 2021 |
| Completion | Jan 20, 2023 |
| First posted | May 22, 2019 |
| Last update posted | Sep 21, 2023 |
| Countries | Austria, Belgium, Bulgaria, Canada, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Japan and 14 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: