Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

Exclusion Criteria

• •1. Subject who meets one of the palivizumab indications already approved in Japan.
• •* Subject born at 28 weeks of gestation or less and who is age of 12 months or less at the start of study drug administration.
• •* Subject born at 29 - 35 weeks of gestation and who is age of 6 months or less at the start of study drug administration.
• •* Subject is age of 24 months or less with a history of bronchopulmonary dysplasia requiring medical management within the 6 months prior to the study drug administration.
• •* Subject is age of 24 months or less with a current hemodynamically significant congenital heart disease at the start of study drug administration.
• •2. Subject requires oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support at Screening and at the start of study drug administration.
• •3. Subject has a current active infection including respiratory syncytial virus infection at Screening and at the start of study drug administration.
• •4. Subject has a serious concurrent medical condition (hepatic dysfunction, persistent seizure disorder, etc.) except those resulting in an immune deficiency condition or renal failure.
• •5. Subject has received palivizumab prior to the study drug administration.
• •6. Subject has received any other investigational agents in the past 3 months or 5 half lives prior to the investigational drug administration (whichever is longer).
• •7. Subject has a history of an allergic reaction or hypersensitivity to constituents of the study drug.
• •8. Subject has a history of serious adverse reactions or serious allergic reaction to immunoglobulin products or has a history of hypersensitivity to immunoglobulin products, blood products, or other foreign proteins.
• •9. Subject whose remaining days of life are expected to be less than one year at the time of informed consent.
• •10. It will be impossible to collect blood as scheduled from the subject.
• •11. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.