MEDI-524 (motavizumab) for the prevention of respiratory sycytial virus (RSV) disease among Native American Indian infants in the southwestern United States

Exclusion Criteria

• - Gestational age less than or equal to 35 weeks
• - Chronic lung disease of prematurity
• - A bleeding diathesis that would preclude IM injections
• - Hospitalization at the time of randomization (unless discharge is anticipated within 10 days)
• - Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
• - A documented wheezing episode before enrollment
• - Known renal impairment
• - Known hepatic dysfunction
• - Clinically significant congenital anomaly of the respiratory tract
• - Chronic seizure or evolving or unstable neurologic disorder
• - Congenital heart disease (CHD) (children with uncomplicated CHD [e.g., Patent ductus arteriosus, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically)
• - Known immunodeficiency
• - Mother with human immunodeficiency virus infection (unless the child has been proven to be not infected)
• - Known allergy to Ig products
• - Receipt of palivizumab, Respiratory syncytial virus immunoglobulin, intravenous (RSV-IGIV), or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B immunoglobulin, IVIG) 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
• - Any medical or social condition which, in the opinion of the investigator, would adversely affect monitoring the infant
• - Inability to complete the study follow-up period through up to 5 years of age