A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness
Condition: Participants Less Than 12 Months of Age With RSV Illness
Intervention: Motavizumab; Placebo
Intervention description: A single IM dose of 30 mg/kg will be administered on Day 0 of the study.; A single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 0 Months
Maximum age: 12 Months
Healthy volunteers: No
Keywords: Respiratory Syncytial Viruses; RSV

Summary:

      This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to
      determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral
      load and motavizumab levels in the upper respiratory tract of children who present with RSV
      illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab
      or placebo will be administered as soon as possible after a child's diagnosis of RSV and
      his/her eligibility for the study has been confirmed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously healthy

          -  Age ≤12 months at the time of randomization

          -  Weight ≤10 kg at the time of randomization

          -  Gestational age ≥36 weeks

          -  RSV illness (must have coryza) documented by a positive RSV test at the time of
             evaluation

          -  Documented stable clinical condition that does not require hospitalization (oxygen
             saturation ≥ 95%; respiratory rate < 60 breaths/minute in children < 2 months and < 50
             breaths/minute in children 2-12 months)

          -  Respiratory Distress Assessment Instrument (RDAI) score of ≤ 6 (there can be no more
             than 1 point assigned for each of the 6 assessment categories) at baseline evaluation

          -  Randomization within 4 hours of being evaluated with a positive Binax® RSV test

          -  Written informed consent obtained from the participant's parent(s) or legal guardian

        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