At a glance
ClinicalIndex Comparison Record- ✓Age ≤24 months at randomization with chronic lung disease of prematurity requiring medical intervention (supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization
- ✓Gestational age ≤35 weeks at birth and age ≤6 months at randomization
- ✕Hospitalized at time of randomization (unless discharge anticipated within 10 days)
- ✕Mechanical ventilation or continuous positive airway pressure (CPAP)
- ✕Life expectancy <6 months
- ✕Active RSV infection (must have negative RSV testing if respiratory symptoms)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating motavizumab (MEDI-524) and palivizumab for Respiratory Syncytial Virus Infections. Completed, enrolled 6,635 participants across 344 sites in 24 countries.
Detailed 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.
Study Details
Timeline
Interventions
Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses