Last reviewed · How we verify
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
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.
Details
| Lead sponsor | MedImmune LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 1236 |
| Start date | 2005-10 |
| Completion | 2008-06 |
Conditions
- Congenital Heart Disease
Interventions
- Motavizumab
- Palivizumab
Primary outcomes
- Number of Subjects Reporting Adverse Events Through Study Day 150 — Days 0-150
Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall. - Number of Subjects Reporting Serious Adverse Events Through Study Day 150 — Days 0-150
Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. - Number of Subjects Reporting Laboratory Adverse Events — Days 0-150
Countries
United States, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Lebanon, Poland, Russia, Spain, Sweden, United Kingdom