Trials / Completed
CompletedNCT00538785
A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,236 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 24 Months
- Healthy volunteers
- Not accepted
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.
Detailed description
The primary objective was to describe the safety and tolerability of motavizumab when given monthly as prophylaxis against serious RSV infection among children with hemodynamically significant congenital heart disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Motavizumab | 15 mg/kg IM administered at monthly intervals |
| BIOLOGICAL | Palivizumab | 15 mg/kg IM administered at monthly intervals |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2007-10-03
- Last updated
- 2012-02-16
- Results posted
- 2012-02-14
Locations
152 sites across 17 countries: United States, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Lebanon, Poland, Russia, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00538785. Inclusion in this directory is not an endorsement.