At a glance
ClinicalIndex Comparison Record- ✓Age ≤6 months at randomization (must be randomized on or before 6-month birthday)
- ✓Male or female Native American
- ✓General state of good health
- ✓Written informed consent from parent(s) or legal guardian
- ✕Gestational age ≤35 weeks
- ✕Chronic lung disease of prematurity
- ✕Active RSV infection or known prior history of RSV infection
- ✕Documented wheezing episode before enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study of MEDI-524 (Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
In Brief
A Phase 3 clinical trial evaluating Motavizumab and Placebo for Healthy. Completed, enrolled 2,127 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
Intramuscular dose of motavizumab 15 mg/kg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.