A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

Phase 1/2 Completed 136 enrolled MedImmune LLC

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

Timeline

Start: 2005-05
Primary completion: 2006-02
Completion: 2006-02

Publications

Results Abarca K, Jung E, Fernandez P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009 Apr;28(4):267-72. doi: 10.1097/INF.0b013e31818ffd03.

Drugs

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

Indications

No indication recorded.