A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants

Exclusion Criteria

• - Diagnosis of CLD of prematurity (also referred to as BPD) or other chronic pulmonary diseases
• - Diagnosis of hemodynamically significant CHD, defined as requiring medication or supplemental oxygen for their CHD
• - Congenital abnormalities of the airways
• - Severe neuromuscular disease, as determined by the investigator
• - Previous or concurrent treatment with palivizumab or intravenous immunoglobulin (IVIG)
• - Eligible for prophylaxis based on local medical standards and guidelines at participating sites
• - Known immunodeficiency
• - Previous or current diagnosis of an upper or lower respiratory infection by a medical professional
• - Previous or current diagnosis of wheezing, asthma, or other wheezing-related diagnoses
• - Hospitalization at the time of enrollment (in case admitted to nursery as part of routine care, infant should only be randomized immediately prior to being discharged)
• - Any illness or condition that would preclude long-term survival
• - Participation in a trial or an investigational agent for RSV prophylaxis or therapy
• - Inability to be followed through their 3rd birthday