Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: Nirsevimab
Intervention description: Single fixed IM dose of nirsevimab 50 mg if body weight < 5 kg or 100 mg if body weight ≥ 5 kg, and subjects entering their second RSV season will receive a single fixed IM dose of nirsevimab 200 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open: no masking is used. All involved know the identity of the intervention assignment.
Enrollment: 100.0
Sex: All
Minimum age: 0 Years
Maximum age: 2 Years
Healthy volunteers: No
Keywords: LRTI by RSV infection

Summary:

      Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the
      safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and
      efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time
      of dose administration. Approximately 100 subjects will be enrolled. Subjects will be
      followed for approximately 1 year after dose administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonate, infant, or young child ≤ 24 months of age at the time of dose administration
             who, per investigator judgement, are:

               1. In their first year of life AND entering their first RSV season at the time of
                  dose administration OR

               2. In their second year of life AND entering their second RSV season at the time of
                  dose administration

          -  The subject must meet at least 1 of the following conditions at the time of informed
             consent.

               1. 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 syndromes, etc); or other immunodeficiency (Wiskott-Aldrich syndrome,
                  DiGeorge syndrome, etc), or

               2. Diagnosed with human immunodeficiency virus infection, or

               3. History of organ or bone marrow transplantation, or

               4. Subject is receiving immunosuppressive chemotherapy, or

               5. Subject is receiving systemic high-dose corticosteroid therapy (prednisone
                  equivalents ≥ 0.5 mg/kg every other day, other than inhaler or topical use), or

               6. Subject is receiving other immunosuppressive therapy (eg, azathioprine,
                  methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine,
                  tacrolimus, cytokine inhibitors, etc)

          -  Written informed consent and any locally required authorization obtained from the
             subject's parent(s)/legal representative(s) prior to performing any protocol-related
             procedures, including screening evaluations.

          -  Subject's parent(s)/legal representative(s) able to understand and comply with the
             requirements of the protocol including follow-up visits as judged by the investigator.

          -  Subject is available to complete the follow-up period, which will be approximately 1
             year after receipt of nirsevimab

        Exclusion Criteria:

          -  Subject who meets any of the palivizumab indications approved in Japan other than
             immunocompromised condition.

               1. Subject born at ≤ 28 weeks gestation and is ≤ 12 months of age

               2. Subject born at 29 to 35 weeks gestation and is ≤ 6 months of age

               3. Age ≤ 24 months with a history of bronchopulmonary dysplasia requiring medical
                  management within the past 6 months

               4. Age ≤ 24 months with current hemodynamically significant congenital heart disease
                  (CHD)

               5. 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.