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.

• Conditions: Serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congential heart disease (CHD).; MedDRA version: 14.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2007-002070-61-Outside-EU/EEA
• Lead Sponsor: MedImmune, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-10
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 800

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: The following children are not eligible: children with uncomplicated small atrial
or ventricular septal defects or patent ductus arteriosus, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone. Children with acyanotic cardiac lesions must have pulmonary hypertension [= 40 mmHg measured pressure in the pulmonary artery (PA)] or the need for daily medication to manage CHD.
3. Unoperated or partially corrected CHD.
4. Written informed consent obtained from the patient’s parent(s)/legal guardian(s).
Are the trial subjects under 18? yes
Number of subjects for this age range: 800
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 illness, or other acute infection or illness.
Note: children with any 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 any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization.
12. Receipt of palivizumab (Synagis®) within 3 months prior to randomization.
13. 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).
14. Current participation in other investigational protocols of drugs or biological agents.
15. Previous participation in MI-CP124 (Season 1).

Study & Design

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