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

Inclusion Criteria:

• Male or female infants born at 32 & 1/7 - 35 & 0/7 weeks GA, determined according to available medical records
• Chronological age of <6 months of age at randomization
• In good health, in the opinion of the investigator

• Not more than one of the following AAP-defined risk factors:

  1. Childcare attendance
  2. School-aged siblings
  3. Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
• Ability and willingness of the subject's parent/legal guardian to complete all protocol-mandated follow-up telephone contacts, visits and procedures
• Written informed consent obtained from the subject's parent(s) or legal guardian

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