A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children
Condition: Healthy or Stable Chronic Illness
MeSH terms: Chronic Disease
Intervention: Q/LAIV (MEDI3250); FluMist/B/Yamagata; FluMist/B/Victoria
Intervention description: 10 ^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria; 10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata; 10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2312.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to demonstrate the immunologic noninferiority of
      Q/LAIV to FluMist in children 2 to 17 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Age 2 through 17 years at the time of randomization

          -  Written informed consent and any locally required authorization (eg, HIPAA in the USA,
             EU Data Privacy Directive in the EU, and written informed assent if applicable)
             obtained from the subject/legal representative prior to performing any
             protocol-related procedures, including screening evaluations

          -  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

          -  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

          -  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

          -  Able to complete follow-up period of 180 days post last dose of vaccine as required by
             the protocol

          -  Subject/legal representative is available by telephone

          -  Child's legal representative is able to understand and comply with the requirements of
             the protocol, as judged by the investigator

        Exclusion Criteria:

          -  Acute illness or evidence of significant active infection at randomization;

          -  Fever ≥ 100.4°F (38.0°C) at randomization

          -  History of asthma, or in children < 5 years of age, history of recurrent wheezing

          -  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.

          -  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

          -  Receipt of immunoglobulin or blood products within 90 days before randomization into
             the study or expected receipt during study participation

          -  Receipt of any investigational drug therapy within 28 days prior to Dose 1 or planned
             receipt of any investigational drug therapy through 90 days after final dosing of
             investigational product (use of licensed agents for indications not listed in the
             package insert is permitted)

          -  Receipt of any nonstudy vaccine within 28 days prior to randomization or planned
             receipt of nonstudy vaccine through 28 days after final dosing

          -  Receipt of any nonstudy seasonal influenza vaccine within 90 days of Dose 1 or planned
             receipt of nonstudy seasonal influenza vaccine prior to 35 days post last dose of
             investigational product

          -  Any known immunosuppressive condition or immune deficiency disease including known or
             suspected infection with human immunodeficiency virus (HIV)

          -  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

          -  Use of aspirin or salicylate-containing products within 28 days prior to randomization
             or expected receipt through 28 days after final vaccination;

          -  History of Guillain-Barré syndrome

          -  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

          -  Known or suspected mitochondrial encephalomyopathy

          -  Pregnant or lactating female

          -  History of alcohol or drug abuse that, in the opinion of the investigator, would
             affect the subject's safety or compliance with study

          -  Any condition that, in the opinion of the investigator, might compromise the safety of
             the subject in the study or would interfere with evaluation of the safety or
             immunogenicity of the investigational products

          -  Subject, legal representative, or immediate family member of subject who is an
             employee of the clinical study site or who is otherwise involved with the conduct of
             the study

          -  A history of epilepsy, seizure, or an evolving neurological condition except that of a
             single febrile seizure that occurred 3 or more years prior to enrollment would not
             disqualify a subject

        Note: an individual who initially is excluded from study participation based on one or more
        of the above time-limited criteria may be reconsidered for enrollment once the condition
        has resolved as long as the subject continues to meet all other entry criteria and the same
        SID number is used