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A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease

NCT00538785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1236

Last updated 2012-02-16

Study results available
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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.

Conditions

  • Congenital Heart Disease

Interventions

BIOLOGICAL

Motavizumab

15 mg/kg IM administered at monthly intervals

BIOLOGICAL

Palivizumab

15 mg/kg IM administered at monthly intervals

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Pamela Griffin, 301-398-0000 · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Lebanon
  • Poland
  • Russia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00538785 on ClinicalTrials.gov