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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00538785

Public ClinicalTrials.gov record NCT00538785. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 6:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00538785
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
MedImmune LLC
Industry
Enrollment
1,236 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
Up to 24 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2005 (Type not available)
Primary completion
Jun 2008 (Actual)
Completion
Jun 2008 (Actual)
Last update posted
Feb 16, 2012

2005 – 2008

United States locations

U.S. sites
30
U.S. states
20
U.S. cities
28
Facility City State ZIP Site status
Arkansas Pediatric Clinic Little Rock Arkansas 72205 —
Miller Children's Hospital Long Beach California 90806 —
Childrens Hospital Los Angeles Los Angeles California 90027 —
Children's Hospital and Research Center at Oakland Oakland California 94609 —
University of California Davis Medical Center Sacramento California 95817 —
Children's Hospital And Health Center San Diego California 92123 —
Yale New Haven Children's Hospital New Haven Connecticut 06520-8064 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Nemours Children's Clinic Biomedical Research Department Orlando Florida 32801 —
James Whitcomb Riley Hospital for Children Indianapolis Indiana 46202 —
Memorial Hospital of South Bend South Bend Indiana 46601 —
Tulane University Health Sciences Center New Orleans Louisiana 70112 —
University of Maryland Baltimore Maryland 21201 —
Johns Hopkins Hospital Baltimore Maryland 21287 —
Tufts - New England Medical Center Boston Massachusetts 02111 —
Children's Hospital Boston Boston Massachusetts 02115 —
Children's Hospital of Michigan Detroit Michigan 48201 —
Mayo Clinic Rochester Minnesota 55905 —
Children's Mercy Hospital Kansas City Missouri 64108 —
Washington University School of Medicine St Louis Missouri 63110 —
University of Rochester Rochester New York 14642 —
Suny At Stony Brook University Medical Center Stony Brook New York 11794 —
Univ. of North Carolina Chapel Hill North Carolina 27599-7220 —
Akron Children's Hospital Akron Ohio 44308 —
Children's Hospital of Oklahoma Oklahoma City Oklahoma 73104 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Rhode Island Hospital Providence Rhode Island 02903 —
Children's Cardiology Associates PLLC Austin Texas 78756 —
Texas Children's Hospital Houston Texas 77030 —
University of Virginia Charlottesville Virginia 22908 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 122 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00538785, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 16, 2012 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00538785 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →