MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States

Phase 3 Completed 2127 enrolled MedImmune LLC

RandomizedParallel-groupQuadruple-blindPrevention

Summary

MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.

Timeline

Start: 2004-11-15
Primary completion: 2010-12-27
Completion: 2010-12-27

Publications

O'Brien KL, Chandran A, Weatherholtz R, Jafri HS, Griffin MP, Bellamy T, Millar EV, Jensen KM, Harris BS, Reid R, Moulton LH, Losonsky GA, Karron RA, Santosham M; Respiratory Syncytial Virus (RSV) Prevention study group. Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy Native American infants: a phase 3 randomised double-blind placebo-controlled trial. Lancet Infect Dis. 2015 Dec;15(12):1398-408. doi: 10.1016/S1473-3099(15)00247-9. Epub 2015 Nov 4.

Drugs

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

Indications

No indication recorded.