Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: motavizumab (MEDI-524); palivizumab
Intervention description: Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses; Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
Intervention MeSH terms: Palivizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6635.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Respiratory Syncytial Virus (RSV); motavizumab; palivizumab; Synagis

Summary:

      The primary objective of this study was to compare the safety and efficacy of motavizumab to
      palivizumab when administered monthly by intramuscular (IM) injection for the reduction of
      the incidence of RSV hospitalization among children at high risk for serious RSV disease. A
      secondary objective was to compare the incidence of medically-attended lower respiratory
      infections (LRIs) between treatment groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  24 months of age or younger at randomization (child must be randomized on or before
             his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of
             prematurity requiring medical intervention/management (i.e., supplemental oxygen,
             bronchodilators, or diuretics) within 6 months before randomization

        OR:

          -  35 weeks gestational age or less at birth and 6 months of age or younger at
             randomization (children were to be randomized on or before his/her 6-month birthday)

        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