Influenza Vaccine Feasibility Study in Children With Persistent Asthma
Condition: Asthmatic
MeSH terms: Influenza, Human; Asthma
Intervention: ccIIV4; IIV4
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study is designed to note whether a larger safety study using quadrivalent live
      attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine
      (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients
      in this study will receive the FLUARIX® influenza vaccine, while the other half will receive
      a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as
      a surrogate for LAIV4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between 5-11 years of age, inclusive, at enrollment.

          -  Participant must have a current diagnosis of persistent asthma.

          -  Parent/legal guardian must provide written informed consent and subject must provide
             assent as appropriate for age prior to initiation of study procedures and according to
             local Institutional Review Board (IRB) requirement.

          -  Parent/legal guardian and subject must be willing and able to comply with planned
             study procedures and be available for all study visits.

          -  Children aged 5-8 years must have received at least 2 doses of seasonal trivalent or
             quadrivalent influenza vaccine prior to the current influenza season. Children 9-11
             years must have received at least 1 dose of seasonal trivalent or quadrivalent
             influenza vaccine prior to the current influenza season.

          -  Is in good health, other than their asthma, as determined by medical history and
             targeted physical examination based on medical history.

          -  English or Spanish literate.

          -  Intention of being available for entire study period and complete all relevant study
             procedures, including follow-up phone calls and collection of information.

        Exclusion Criteria:

          -  Acute illness and/or a reported oral temperature of ≥ 100.4°F within 72 hours prior to
             enrollment (this may result in a temporary delay of vaccination.

          -  Use of antipyretic medication during the preceding 24 hours that might mask a fever
             (temporary deferral).

          -  History of a severe allergic reaction (e.g., anaphylaxis) to any component of study
             influenza vaccines or a known allergy to eggs.

          -  Receipt of any licensed vaccine within 14 days (for inactivated vaccines) or 28 days
             (for live vaccines) prior to vaccination or planned receipt of any licensed vaccine
             within 42 days after vaccination.

          -  Receipt of current year's licensed influenza vaccine.

          -  Received an investigational agent (licensed or unlicensed vaccine, drug, biologic,
             device, blood product, or medication) in the 28 days prior to enrollment or planned
             receipt before 42 days after vaccination.

          -  Has immunosuppression as a result of an underlying illness or treatment, or use of
             anticancer chemotherapy or radiation therapy within the preceding 36 months.

          -  Has taken ≥ 20mg/day of prednisone or its equivalent, for 14 days or more within the
             past 28 days.

          -  Has know active neoplasm or a history of any hematologic malignancy.

          -  Has had a previous exacerbation of their asthma symptoms requiring systemic steroids
             within the prior 28 days, or has had a life-threatening exacerbation of asthma in the
             past two years (e.g. hypoxic seizure, mechanical ventilation).

          -  History of Guillian-Barre syndrome within 6 weeks of previous influenza vaccination.

          -  Has any condition that, in the opinion of the investigator, would interfere with the
             evaluation of the responses or would place the participant at unacceptable risk of
             injury.

          -  Has any diagnosis, current or past, of schizophrenia, bipolar disease, or other major
             psychiatric disorder.

          -  Currently taking aspirin or aspirin-containing products.