A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years
Condition: Healthy Japanese Children Age 7 Years Through 18 Years
Intervention: MEDI3250; Placebo
Intervention description: MEDI3250; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1369.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Efficacy; Safety; Tolerability; MEDI3250; Japanese children

Summary:

      The study is designed to gather the efficacy, safety and tolerability data in Japanese
      children 7 to 18 years of age that would support approval of MEDI3250 in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 7 through 18 years of age at the time of randomization.

          2. A written informed consent should be obtained from the subject's legally acceptable
             representative, and a written informed assent should be obtained from the subject if
             possible.

          3. Available for illness visits at clinic during the influenza surveillance period.

          4. Ability of the legal representative to understand and comply with the requirements of
             the protocol．

          5. Parent/guardian available by telephone, email or etc．

          6. Females of childbearing potential, unless surgically sterile (ie, bilateral tubal
             ligation, bilateral oophorectomy, or hysterectomy), has sterile male partner, is
             premenarchal, or practices abstinence, must have used an effective method of avoiding
             pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine
             device, female condom with spermicide, diaphragm with spermicide, cervical cap with
             spermicide, or use of a condom with spermicide by the sexual partner) for 30 days
             prior to the first dose of investigational product, and must agree to continue using
             such precautions for 60 days after the final dose of investigational product.

          7. A subject who is considered by the investigator to be at risk of pregnancy must also
             have a negative urine pregnancy test at screening and, if screening and Day 0 do not
             occur on the same day, on the day of vaccination prior to randomization. Investigator
             judgment is required to assess each subject's need for pregnancy testing.

          8. 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.

        Exclusion Criteria:

          1. Subjects who were previously administered influenza vaccine in 2014-2015 influenza
             season

          2. Previous randomisation in the present study

          3. Participation in another clinical study with an investigational product during the
             last 3 month

          4. Acute illness or evidence of significant active infection at randomization;

          5. Fever ≥99.5°F (37.5°C) at randomization;

          6. 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:

             Contraceptives (change in contraceptive type or method is acceptable as long as
             guidelines are followed for prevention of pregnancy during change); 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.

          7. 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.

          8. Any known immunosuppressive condition or immune deficiency disease including known or
             suspected infection with human immunodeficiency virus (HIV);

          9. 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;

         10. Use of aspirin or salicylate-containing medications within 28 days prior to
             randomization or expected receipt through the entire study;

         11. History of Guillain-Barré syndrome;

         12. 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 in the study period;

         13. 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;

         14. 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;

         15. Receipt of any blood product within 90 days prior to vaccination or expected receipt
             during this study;

         16. Pregnant or lactating female

         17. Involvement in the planning and conduct of the study (applies to all AstraZeneca staff
             and staff at the study site as a legal representative)

         18. Any condition that, in the opinion of the investigator, might interfere with the
             interpretation or evaluation of the vaccines.