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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus Infections
In brief
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
Key facts
- Study ID
- NCT03979313
- Run by
- AstraZeneca
- People needed
- 3012
- Starts
- 2019-07-23
- Expected to finish
- 2023-03-21
- Last updated by the study team
- 2024-02-28
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: accepted.
Where it is running
- Research Site — Fort Defiance, Arizona, United States
- Research Site — Fayetteville, Arkansas, United States
- Research Site — Anaheim, California, United States
- Research Site — Downey, California, United States
- Research Site — National City, California, United States
- Research Site — Paramount, California, United States
- Research Site — West Covina, California, United States
- Research Site — Aurora, Colorado, United States
- Research Site — Colorado Springs, Colorado, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — Gainesville, Florida, United States
- Research Site — Hialeah, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Fort Gordon, Georgia, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Oak Lawn, Illinois, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — West Des Moines, Iowa, United States
- Research Site — Bardstown, Kentucky, United States
- Research Site — Lexington, Kentucky, United States
- Research Site — Shreveport, Louisiana, United States
- Research Site — Jackson, Mississippi, United States
- Research Site — Columbia, Missouri, United States
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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