A study to evaluate the safety of MEDI8897 for the prevention of medically attended Respiratory Syncytial Virus(RSV) lower respiratory track infection (LRTI) in high-risk children

Exclusion Criteria

• 1 Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
• 2 Any history of LRTI or active LRTI prior to, or at the time of, randomization
• 3 Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
• 4 Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
• 5 Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
• 6 Anticipated cardiac surgery within 2 weeks after randomization
• 7 Anticipated survival of < 6 months after randomization
• 8 Receipt of any investigational drug
• 9 Known renal impairment
• 10 Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
• 11 Clinically significant congenital anomaly of the respiratory tract
• 12 Chronic seizure, or evolving or unstable neurologic disorder
• 13 Prior history of a suspected or actual acute life-threatening event
• 14 Known immunodeficiency, including human immunodeficiency virus (HIV)
• 15 Mother with HIV infection (unless the child has been proven to be not infected)
• 16 Any known allergy, including to immunoglobulin products, or history of allergic reaction
• 17 Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
• 18 Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
• 19 Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
• 20 Concurrent enrollment in another interventional study
• 21 Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals