Trials / Completed
CompletedNCT00129766
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6,635 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 24 Months
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | motavizumab (MEDI-524) | Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
| BIOLOGICAL | palivizumab | Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses |
Timeline
- Start date
- 2004-11-01
- Primary completion
- 2006-05-01
- Completion
- 2006-05-01
- First posted
- 2005-08-12
- Last updated
- 2013-08-28
- Results posted
- 2013-08-28
Locations
344 sites across 24 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Israel, Italy, New Zealand, Poland, Russia, Spain, Sweden, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT00129766. Inclusion in this directory is not an endorsement.