MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
Condition: Healthy
Intervention: Motavizumab; Placebo
Intervention description: Intramuscular dose of motavizumab 15 mg/kg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.; Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2127.0
Sex: All
Minimum age: 0 Months
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: RSV, infants, Native American Indians

Summary:

      MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to
      determine if motavizumab is more effective than placebo in reducing RSV hospitalization in
      otherwise healthy Native American Infants in the Southwestern United States during their
      first RSV season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 months of age or younger at randomization (child must be randomized on or before
             their 6-month birthday)

          -  Male or female Native American

          -  General state of good health

          -  Written informed consent obtained from the participant's parent(s) or legal guardian

        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