Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
Condition: Respiratory Syncytial Virus Prophylaxis
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: Motavizumab; Motavizumab; Motavizumab; Placebo
Intervention description: Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0; Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0; Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0; Single dose of placebo administered intravenously (in the vein) on Day 0
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: MEDI-524; Motavizumab; respiratory syncytial virus; children; intravenous; Rezield

Summary:

      The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a
      single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously healthy

          -  Age 24 months and younger at the time of randomization

          -  Gestational age of 36 weeks gestation and older

          -  Randomization within 24 hours after hospitalization

          -  Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus
             (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or
             culture in respiratory secretions within 72 hours before randomization

        Exclusion Criteria:

          -  Already received or would receive ribavirin or other anti-viral treatment for the
             current episode of RSV infection prior to randomization

          -  Required intubation for ventilatory support

          -  Any medically significant underlying ongoing chronic illness or organ system
             dysfunction or other known acute illness, other than RSV infection

          -  Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or
             other neurologic disorder or immunodeficiency

          -  Requirement for supplemental oxygen at any time prior to the current RSV infection
             (brief use of oxygen in the immediate postnatal period to treat a transient condition
             was allowed)

          -  Mechanical ventilation at any time prior to the onset of the current RSV infection

          -  Congenital heart disease (children with medically or surgically corrected patent
             ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect
             [VSD] were allowed)

          -  Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other
             foreign proteins

          -  Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin
             products 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