Study identifier:MI-CP110
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Respiratory Syncytial Virus Infections
Phase 3
No
-
All
6635
Interventional
0 Months - 24 Months
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Jun 2013 by MedImmune LLC
MedImmune LLC
-
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.
Location
Location
Buenos Aires, Argentina, C1270AAN
Location
Cordoba, Argentina, C5000BJH
Location
Buenos Aires, Argentina, B1754FWE
Location
Capital Federal, Argentina, C145AIN
Location
Sao Paulo, Brazil, 04378-500
Location
Sao Paulo, Brazil, 01221-020
Location
Ribeirao Preto, Brazil, 14048-900
Location
Curitiba, Brazil, 80010-100
Arms | Assigned Interventions |
---|---|
Active Comparator: palivizumab 15 mg/kg administered intramuscularly for 5 monthly doses | Biological/Vaccine: palivizumab Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Other Name: Synagis |
Experimental: motavizumab (MEDI-524) 15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses | Biological/Vaccine: motavizumab (MEDI-524) Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses Other Name: MEDI-524 |
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