(Medley)-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)

Brief description of study

In this study, MEDI8897 is being compared to Synagis® to determine if the effectiveness and safety of MEDI8897 is similar to Synagis®.MEDI8897 is a drug that is being evaluated to determine if it is effective in preventing lower respiratory tract infection due to Respiratory Syncytial Virus (RSV). Currently, the only approved drug for the prevention of serious RSV disease is palivizumab (Synagis®) which requires monthly injections for about 5 shots during the typical RSV season. MEDI8897 is active for a longer period of time and it is expected that one shot will provide protection for the entire RSV season.


Clinical Study Identifier: s19-01266
ClinicalTrials.gov Identifier: NCT03959488
Principal Investigator: Leonard R Krilov.


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