A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness

The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.

The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.

Inclusion Criteria:

Children must meet all of the following criteria:

• Previously healthy
• Age less or equal to 12 months at the time of randomization
• Gestational age more or equal to 36 weeks
• Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)
• Documented positive RSV test within 48 hours prior to randomization
• Randomization within 12 hours of the decision to hospitalize a child for RSV illness
• Written informed consent obtained from the participant's parent(s)/legal guardian

Exclusion Criteria:

Children must have none of the following:

• Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
• Any use of systemic or inhaled steroids within the past 30 days prior to randomization
• Intubation for ventilatory support at randomization
• Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for 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 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 arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
• Previous reaction to IVIG, blood products, or other foreign proteins
• Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months
• Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization
• Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV