At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 925 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 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
In Brief
A Phase 3 clinical trial evaluating MEDI8897 and Palivizumab for Respiratory Syncytial Virus Infections. Completed, enrolled 925 participants across 128 sites in 26 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesAustria, Belgium, Bulgaria, Canada, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartJul 2019
Primary CompletionMay 2021
Study CompletionJan 2023
TodayJul 2026
First PostedMay 22, 2019
Enrollment StartJul 30, 2019
Primary CompletionMay 3, 2021
Study CompletionJan 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.1 years ago
Interventions
MEDI8897drug
Anti-RSV monoclonal antibody with an extended half-life
Palivizumabdrug
Approved anti-RSV monoclonal antibody