NCT03979313

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)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,012 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 0 Years – 1 Year
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	MEDI8897	Anti-RSV monoclonal antibody with an extended half-life
DRUG	Placebo	Commercially available 0.9% (w/v) saline

Timeline

• Start date: 2019-07-23
• Primary completion: 2021-03-11
• Completion: 2023-03-21
• First posted: 2019-06-07
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

198 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study