Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

Phase 3 Completed 6635 enrolled MedImmune LLC

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

Timeline

Start: 2004-11
Primary completion: 2006-05
Completion: 2006-05

Outcome

Met primary endpoint

paper Motavizumab recipients had a 26% relative reduction in RSV hospitalization compared with palivizumab recipients, achieving noninferiority. PMID 20008423 ↗

Publications

Results Carbonell-Estrany X, Simoes EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA; Motavizumab Study Group. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics. 2010 Jan;125(1):e35-51. doi: 10.1542/peds.2008-1036. Epub 2009 Dec 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Motavizumab	Monoclonal antibody	15 mg/kg	Intramuscular
Comparator	Palivizumab	Monoclonal antibody	15 mg/kg	Intramuscular