A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab

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:
• •1. Known renal impairment
• •2. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
• •3. 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