Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children - MUSIC

Exclusion Criteria

• - Subject who meets any of the palivizumab indications approved in Japan other than immunocompromised condition.
• a) Subject born at ≤ 28 weeks gestation and is ≤ 12 months of age
• b) Subject born at 29 to 35 weeks gestation and is ≤ 6 months of age
• c) Age ≤ 24 months with a history of bronchopulmonary dysplasia requiring medical management within the past 6 months
• d) Age ≤ 24 months with current hemodynamically significant congenital heart disease (CHD)
• e) Age ≤ 24 months with Down syndrome
• - Requirement for oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, or other mechanical respiratory or cardiac support at screening
• - A current, active infection, including RSV infection, at the time of screening or at the time of investigational product administration.
• - Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to investigational product administration.
• - Any serious concurrent medical condition (renal failure, hepatic dysfunction, suspected active or chronic hepatitis infection, seizure disorder, unstable neurologic disorder, etc), except those resulting in an immune deficiency condition.
• - Clinically significant congenital anomaly of the respiratory tract.
• - Receipt of palivizumab.
• - Any known allergy or history of allergic reaction to any component of nirsevimab.
• - Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins.
• - Concurrent enrollment in another interventional study, or prior receipt of any investigational agent.
• - Anticipated survival of less than 1 year at the time of informed consent.
• - Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results.
• - 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.