Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China

Exclusion Criteria

• •1. Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to investigational product administration
• •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. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) that may be permitted according to the judgment of the Investigator
• •5. Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the Investigator)
• •6. History of receipt of blood products, or immunoglobulin products, or expected receipt through the duration of the study
• •7. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
• •8. Known renal impairment
• •9. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
• •10. History of CLD/bronchopulmonary dysplasia
• •11. Clinically significant congenital anomaly of the respiratory tract
• •12. CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect)
• •13. Chronic seizure, or evolving or unstable neurologic disorder
• •14. Prior history of a suspected or actual acute life-threatening event
• •15. Known immunodeficiency, including human immunodeficiency virus (HIV)
• •16. Mother with HIV infection (unless the child has been proven to be not infected)
• •17. Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins, or history of allergic reaction
• •18. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
• •19. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV immunoglobulin) or anticipated use during the study
• •20. Receipt of any investigational product
• •21. Concurrent enrollment in another interventional study
• •22. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of study results
• •23. 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