Clinical trial
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of…
NCT03979313 · AstraZeneca, Industry · Completed
Key facts
| NCT number | NCT03979313 |
|---|---|
| Title | A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY) |
| Official title | A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY) |
| Acronym | MELODY |
| Lead sponsor | AstraZeneca, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Respiratory Syncytial Virus Infections |
| Intervention type | Drug |
| Interventions | MEDI8897, Placebo |
| Enrollment | 3,012 |
| Start date | Jul 23, 2019 |
| Primary completion | Mar 11, 2021 |
| Completion | Mar 21, 2023 |
| First posted | Jun 7, 2019 |
| Last update posted | Feb 28, 2024 |
| Countries | Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France and 19 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: