A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years
Condition: Healthy Japanese Children Age 2 Years Through 6 Years
Intervention: MEDI3250
Intervention description: MEDI3250
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Safety; Tolerability; MEDI3250; Japanese children

Summary:

      This open-label, single arm, multicenter study will enroll approximately 100 subjects. The
      study is designed to gather the safety and tolerability data in Japanese children 2 to 6
      years of age that would support approval of MEDI3250 in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy by medical history and physical examination OR presence of stable underlying
             chronic medical condition for which hospitalization has not been required in the
             previous year.

          2. Age 2 through 6 years of age at the time of administration.

          3. A written informed consent should be obtained from the subject's legally acceptable
             representative.

          4. Ability of the parent/guardian to understand and comply with the requirements of the
             protocol．

          5. Parent/guardian available by telephone or email．

        Exclusion Criteria:

          1. Previous administration in the present study

          2. Participation in another clinical study with an investigational product during the
             last 3 month

          3. Acute illness or evidence of significant active infection at time of investigational
             product administration

          4. Fever ≥99.5°F (37.5°C) at time of investigational product administration

          5. Any drug therapy from 15 days prior to randomization or expected drug therapy through
             28 days post last dose with the exception of the following classes/types of
             medications, which are allowed:

             Topical corticosteroids, calcineurin inhibitors, or antifungals for uncomplicated
             dermatitis; Chronic medications (including those taken on an as-needed basis) that
             have been well tolerated and were not initiated and/or did not have a dosage change
             within 90 days prior to randomization.

          6. Current or expected receipt of immunosuppressive medications within a 28-day window
             around any dose, including an immunosuppressive dose of corticosteroids, which is
             defined as ≥20 mg/day of prednisone or its equivalent, given daily or on alternate
             days for ≥15 days (intranasal, intra-articular, and topical corticosteroids are
             permitted); Note: topical corticosteroids for uncomplicated dermatitis may be used
             throughout the study according to the judgment of the investigator; topical
             calcineurin inhibitors may be used in accordance with their package insert at entry
             and during study participation.

          7. Any known immunosuppressive condition or immune deficiency disease including known or
             suspected infection with human immunodeficiency virus (HIV);

          8. History of allergic disease or reactions likely to be exacerbated by any component of
             the investigational product including allergy to eggs, egg proteins, gentamicin, or
             gelatin or serious, life threatening, or severe reactions to previous influenza
             vaccinations;

          9. Use of aspirin or salicylate-containing medications within 28 days prior to enrolment
             or expected receipt through 28 days after final vaccination;

         10. History of Guillain-Barré syndrome;

         11. Use of antiviral agents with activity against influenza virus (including amantadine,
             rimantadine, oseltamivir, and zanamivir) within 28 days prior to first dose of
             investigational product or anticipated use of such agents within 28 days after last
             scheduled vaccination;

         12. Administration of any live virus vaccine within 30 days prior to enrolment, or if
             receipt of another live virus vaccine is expected within 30 days of any study
             vaccination;

         13. Administration of any inactivated vaccine within 14 days prior to enrolment or if
             receipt of another inactivated vaccine is expected within 14 days of any study
             vaccination;

         14. Receipt of any blood product within 90 days prior to vaccination or expected receipt
             during this study;

         15. Involvement in the planning and conduct of the study (applies to all AstraZeneca staff
             and staff at the study site as a parent/guardian)

         16. Any condition that, in the opinion of the investigator, might interfere with the
             interpretation or evaluation of the vaccines.