Study identifier:D5290C00004
ClinicalTrials.gov identifier:NCT03979313
EudraCT identifier:2019-000114-11
CTIS identifier:N/A
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)
Respiratory Syncytial Virus Infections
Phase 3
Yes
MEDI8897, Placebo
All
3012
Interventional
0 Years - 1 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verified 01 May 2025 by AstraZeneca
AstraZeneca
-
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.
This pivotal Phase 3 study will determine if MEDI8897 will prevent medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy infants entering their first RSV season. The population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (GA) who would not be eligible to receive RSV prophylaxis. A total of approximately 3,000 infants will be randomized 2:1 to receive either MEDI8897 or placebo. All subjects will be followed for approximately 510 days after dosing. Enrollment is planned at approximately 350 sites across the USA, Canada, Europe, Asia, and Southern Hemisphere.
Location
Location
Boone, NC, United States, 28607
Location
North Charleston, SC, United States, 29406
Location
Oklahoma City, OK, United States, 73104
Location
Charlottesville, VA, United States, 22902
Location
Gainesville, FL, United States, 32653
Location
Kingsport, TN, United States, 37660
Location
San Antonio, TX, United States, 78249
Location
San Juan de Alicante, Spain, 03550
Arms | Assigned Interventions |
---|---|
Experimental: MEDI8897 Anti-RSV monoclonal antibody with an extended half-life | Drug: MEDI8897 Anti-RSV monoclonal antibody with an extended half-life |
Placebo Comparator: Placebo Commercially available 0.9% (w/v) saline | Drug: Placebo Commercially available 0.9% (w/v) saline |
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