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

Exclusion Criteria

• - Unstable cardiac or respiratory status, including cardiac defects so severe that survival was not expected or for which cardiac transplantation was planned or anticipated
• - Hospitalization, unless discharge was anticipated within 21 days
• - Anticipated cardiac surgery within two weeks of randomization
• - Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
• - Associated non-cardiac anomalies or end organ dysfunction resulting in anticipated survival of less than six months or unstable abnormalities of end organ function
• - Acute respiratory illness, or other acute infection or illness
• Note: children with any respiratory symptoms must have had a negative RSV test prior to randomization
• - Chronic seizure or evolving or unstable neurologic disorder
• - Known immunodeficiency
• - Mother with HIV infection (unless the child had been proven to be not infected)
• - Known allergy to Ig products
• - Receipt of any polyclonal antibody (for example, Hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
• - Receipt of palivizumab (Synagis®) within 3 months prior to randomization
• - 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)
• - Current participation in other investigational protocols of drugs or biological agents
• - Previous participation in MI-CP124 (Season 1)