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

Phase 1

• Conditions: Serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congential heart disease (CHD).; MedDRA version: 7.0Level: PTClassification code 10061603

• Registration Number: EUCTR2005-001671-35-GB
• Lead Sponsor: MedImmune, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-21
• Study Completion: 2008-06-26
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1235

Inclusion Criteria

Children must meet all of the following criteria:
1. 24 months of age or younger at randomization (child must be randomized on or before their 24-month birthday)
2. Documented, hemodynamically significant CHD Note: Children with uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus are not eligible
3. Unoperated or partially corrected CHD
4. Written informed consent obtained from the patient’s parent(s) or legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Children must have none of the following:
1. Unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated
2. Hospitalization, unless discharge is anticipated within 21 days
3. Anticipated cardiac surgery within two weeks of randomization
4. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
5. Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function
6. Acute respiratory or other acute infection or illness (children with respiratory symptoms must have a negative RSV test prior to randomization)
7. Chronic seizure or evolving or unstable neurologic disorder
8. Known immunodeficiency
9. Mother with HIV infection (unless the child has been proven to be not infected)
10. Known allergy to Ig products
11. Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
12. Use of investigational agents within the past three months (other than investigational agents commonly used during cardiac surgery or the immediate post-operative period, e.g., nitric oxide)
13. Current participation in other investigational protocols of drugs or biological agents

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified