At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,012 enrolled
Drug / intervention
MEDI8897 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating MEDI8897 and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 3,012 participants across 198 sites in 31 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartJul 2019
Primary CompletionMar 2021
Study CompletionMar 2023
TodayJul 2026
First PostedJun 7, 2019
Enrollment StartJul 23, 2019
Primary CompletionMar 11, 2021
Study CompletionMar 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.1 years ago
Interventions
MEDI8897drug
Anti-RSV monoclonal antibody with an extended half-life
Placebodrug
Commercially available 0.9% (w/v) saline