Study of Palivizumab in Children with High Risk of Severe Respiratory Syncytial Virus (RSV) Disease - Synagis

Exclusion Criteria

• Participants are excluded from the study if any of the following criteria apply:
• 1. Hospitalisation at the time of enrolment, unless the discharge is expected within 30 days of the time of enrolment
• 2. Required mechanical ventilation (including continuous positive airway pressure) or other mechanical respiratory or cardiac support at the time of enrolment.
• 3. Anticipated cardiac surgery within 2 weeks after enrolment.
• 4. Anticipated survival of < 6 months after enrolment in the trial.
• 5. Active LRTD, including RSV infection at the time of enrolment and/or study intervention administration.
• 6. Any fever (≥ 38.0°C) or acute illness within 7 days prior to investigational product administration.
• 7. Known history of evolving or unstable neurologic disorder.
• 8. Known history of unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated.
• 9. Known allergy, including to immunoglobulin products, or history of allergic reaction.
• 10. Receipt of palivizumab or other RSV monoclonal antibodies or any RSV vaccine, including maternal RSV vaccination.
• 11. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study.
• 12. Concurrent enrolment in another interventional study.
• 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.
• 14. Judgment by the investigator that the participant should not participate in the study if the participant or the participant's parent/legal guardian is unlikely to comply with study procedures, restrictions, and requirements.