A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children
A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children
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.
A randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere. Each child only participated during a single RSV season. Approximately 6,600 children at risk for serious RSV disease were to be randomized in a 1:1 ratio to receive either 15 mg/kg of palivizumab or motavizumab by IM injection every 30 days for a total of 5 doses.
Inclusion Criteria:
OR:
Exclusion Criteria:
Cook, Illinois 60453, United States
Stony Brook, New York 11794, United States
Mahaning, Ohio 44501, United States
Sioux Falls, South Dakota 57117, United States
Capital Federal, C145AIN, Argentina
Porto Alegre, 90610-000, Brazil
Plovdiv, 4000, Bulgaria
Plovdiv, 4002, Bulgaria
Sofia, 1431, Bulgaria
Plzen-Bory, 305 99, Czechia
Plzen-Lochotin, 304 60, Czechia
Halle, 06120, Germany
Oldenberg, 26133, Germany
Ancona, 60123, Italy
Bergamo, 24128, Italy
Lecco, 23900, Italy
Udine, 33100, Italy
Bydgoszcz, 85-168, Poland
Lodz, 91-738, Poland
Lublin, 20-093, Poland
Guipuzcoa, 20014, Spain
Ankara, 06100, Turkey (Türkiye)
Dundee, DD1 9SY, United Kingdom
Gillingham Kent, ME7 5NY, United Kingdom
Hants, SO16 5YA, United Kingdom