Safety of LAIV4 in Children With Asthma
Condition: Asthma in Children; Vaccine Adverse Reaction; Vaccine Reaction; Asthma; Wheezing; Influenza
MeSH terms: Influenza, Human; Asthma; Respiratory Sounds
Intervention: Live Attenuated Influenza Vaccine (LAIV); Inactivated Influenza Vaccine (IIV)
Intervention description: 1 dose, 0.2 mL, intranasal administration; 1 dose, 0.5 mL, intramuscular administration
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: asthma; influenza vaccine; inactivated influenza vaccine; live attenuated influenza vaccine

Summary:

      This is a prospective randomized, open label clinical trial in approximately 300 children
      aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be
      randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV
      (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between 5-11 years of age, inclusive, at enrollment

          -  Participant must have a current diagnosis of persistent asthma (Physician diagnosis of
             asthma and current prescribed use of a long-acting controller medication. For purposes
             of this study, we have considered "controller" medications to be any single or
             combination use of long-acting medications used to prevent asthma exacerbations and to
             achieve long-term control of asthma (as compared to short-acting rescue medication).)

          -  Parent(s) or legal guardian(s) must provide written, informed consent and participant
             must provide assent as appropriate for age prior to initiation of study procedures and
             according to local IRB requirements

          -  Parent(s) or legal guardian(s) and participant must be willing and able to comply with
             planned study procedures and be available for all study visits

          -  Is in good health, other than their asthma, as determined by medical history

          -  English or Spanish literate (only English-speaking participants will be included at
             the Cincinnati and Duke sites)

          -  Intention of being available for entire study period and complete all relevant study
             procedures, including follow-up using at least one of the following methods: phone
             calls, text messages, or emails

        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
             (this may result in a temporary delay of vaccination)

          -  History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any
             influenza vaccine or after any component of the influenza vaccine, including egg
             protein.

          -  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 (2018-2019 influenza season) licensed influenza vaccine for
             children 9-11 years (only). (Clarification: Children aged 5-8 years are permitted to
             be enrolled if they have received zero or one dose of the 2018-2019 influenza season
             vaccine, and require two doses of the 2018-2019 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

          -  Have immunosuppression as a result of an underlying illness or treatment, or use of
             anticancer chemotherapy or radiation therapy within the preceding 36 months

          -  Have taken ≥20mg/day of prednisone or its equivalent, for 14 days or more within the
             past 28 days

          -  Have known 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)

          -  Received influenza antiviral medication within 48 hours prior to study vaccination

          -  History of Guillian-Barré syndrome within 6 weeks of previous influenza vaccination

          -  Have 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 a positive urine or serum pregnancy test within 24 hours prior to vaccination in a
             post-menarchal female. LAIV is not recommended for use in pregnant females.

          -  Currently taking aspirin or aspirin-containing products

          -  Any parent(s) or legal guardian(s) who is an immediate relative of study staff or is
             an employee supervised by study staff.