Study of MEDI-524 (motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

Exclusion Criteria

• - Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
• - Mechanical ventilation or other mechanical support (including continuous positive airways pressure [CPAP])
• - Life expectancy < 6 months
• - Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
• - Known renal impairment
• - Known hepatic dysfunction
• - Chronic seizure or evolving or unstable neurologic disorder
• - Congenital heart disease [CHD] (children with uncomplicated CHD [e.g., patent ductus arterious (PDA), small septal defect] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
• - Known immunodeficiency
• - Mother with HIV infection (unless the child has been proven to be not infected)
• - Known allergy to Ig products
• - 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
• - Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
• - Previous receipt of RSV vaccines
• - Participation in other investigational drug product studies