Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
Condition: Respiratory Syncytial Virus Infection
MeSH terms: Virus Diseases; Respiratory Syncytial Virus Infections
Intervention: Palivizumab
Intervention MeSH terms: Palivizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Immunocompromised medical conditions; Respiratory Syncytial Virus Infection; Infant; Newborn; Young children

Summary:

      To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24
      months or less with immunocompromised medical conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Availability of parent or legal guardian who is capable and willing to give written
             informed consent for his/her newborn, infant or young child to participate this study.

          2. Japanese newborn, infant or young child at age of 24 months or less.

          3. The subject must meet at least one of the following immunocompromised medical
             conditions (from [a] to [h]), and must be considered by the investigator to be a
             suitable candidate to receive prophylactic treatment of palivizumab:

               1. Subject has been diagnosed with combined immunodeficiency (severe combined
                  immunodeficiency, X-linked hyper-immunoglobulin M (IgM) syndrome, etc.), antibody
                  deficiency (X-linked agammaglobulinemia, common variable immunodeficiency,
                  non-X-linked hyper-IgM syndrome, etc.) or other immunodeficiency (Wiskott-Aldrich
                  syndrome, DiGeorge syndrome, etc.) at the time of informed consent, or

               2. Subject has been diagnosed with human immunodeficiency virus infection, or

               3. Subject has been diagnosed with Down syndrome without a current hemodynamically
                  significant congenital heart disease at the time of informed consent (subject
                  must have an experience with persistent respiratory symptom or regular outpatient
                  treatment due to respiratory tract infection prior to current RSV season), or

               4. Subject has a history of post organ transplantation at the time of informed
                  consent, or

               5. Subject has a history of post bone marrow transplantation at the time of informed
                  consent, or

               6. Subject is receiving immunosuppressive chemotherapy at the start of study drug
                  administration, or

               7. Subject is receiving systemic high dose corticosteroid therapy (prednisone
                  equivalents 0.5 mg/kg or more every other day, other than inhaler or topical use)
                  at the start of study drug administration, or

               8. Subject is receiving other immunosuppressive therapy (azathioprine, methotrexate,
                  mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus,
                  cytokine inhibitors, etc.) at the start of study drug administration.

        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.