A study to assess safety, pharmacokinetics Anti-Drug Antibody and anti-RSV antibody after 2 doses of nirsevimab - JUBILUS

Exclusion Criteria

• 1.Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure (CPAP), or other mechanical respiratory or cardiac support at the time of enrollment
• 2.A current, active RSV infection at the time of screening and investigational product administration
• 3.Any fever (≥100.4°F [≥38.0°C], regardless of route) or acute illness at the time of prior to investigational product administration
• 4.Any serious concurrent medical condition (except those resulting in an immune deficiency condition), including:
• (a) Known renal impairment
• (b) Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
• (c) Any seizure disorder or evolving or unstable neurological condition
• 5.Anticipated cardiac surgery within 5-6 months after enrollment
• 6.Prior history of a suspected or actual acute life-threatening event
• 7.Receipt or intended use of palivizumab in the current enrollment season
• 8.Any known allergy or history of allergic reaction to any component of nirsevimab
• 9.Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins
• 10.Concurrent enrollment in another interventional study, or prior receipt of any investigational agent
• 11.Anticipated survival of less than 1 year at the time of informed consent
• 12.Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of study results
• 13.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