At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,236 enrolled
Drug / intervention
Motavizumab +1 morebiological
Likely dose
Motavizumab 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease
In Brief
A Phase 2 clinical trial evaluating Motavizumab and Palivizumab for Congenital Heart Disease. Completed, enrolled 1,236 participants across 152 sites in 17 countries.
Detailed Summary
The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease
CountriesAustria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Lebanon, Poland, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
First PostedOct 2007
Primary CompletionJun 2008
TodayJul 2026
First PostedOct 3, 2007
Enrollment StartOct 1, 2005
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.7 years ago
Interventions
Motavizumabbiological
15 mg/kg IM administered at monthly intervals
Palivizumabbiological
15 mg/kg IM administered at monthly intervals