A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness

Exclusion Criteria

• •Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
• •Prior medically diagnosed RSV infection
• •Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
• •Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
• •Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
• •Requirement for supplemental oxygen (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
• •Mechanical ventilation at any time prior to the onset of the current RSV infection
• •Congenital heart disease \[children with medically or surgically closed patent ductus arteriosus (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed\]
• •Previous reaction to intravenous immunoglobulin (IVIG), blood products, or other foreign proteins
• •Prior use of IVIG, RSV-IGIV (RespiGam®), motavizumab or other immunoglobulin products within the past 2 months
• •Prior use of palivizumab (Synagis®) within the past 2 months
• •Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
• •Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV