Influenza Vaccine Feasibility Study in Children With Persistent Asthma
Condition: Asthmatic
MeSH terms: Influenza, Human; Asthma
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The association of an increased risk in wheezing following receipt of a live-attenuated
      influenza vaccine in children at least 2 years of age with a prior history of asthma or
      wheeze remains unclear.

      The Centers for Disease Control (CDC) and Prevention's Clinical Immunization Safety
      Assessment (CISA) planned to address a data safety gap regarding use of LAIV4 vaccine in
      children with asthma by conducting a 3-site randomized, non-inferiority prospective study.
      The main goal was to compare the safety of LAIV4 versus IIV4 in children 5-11 years with
      persistent asthma during the 2016-2017 influenza season. CDC and the CISA study sites
      developed a protocol and associated materials, and were poised to begin enrollment early
      during the 2016-2017 influenza season. However, after the June 22, 2016 Advisory Committee on
      Immunization Practices (ACIP) vote recommending against use of LAIV4 during the 2016-2017
      influenza season, CDC and study investigators decided to defer implementing a study using
      LAIV4 during the 2016-2017 influenza season. Investigators will reconsider initiating this
      study during the 2017-2018 influenza season if ACIP votes to reinstate LAIV4 use or new data
      become available; ACIP makes recommendations annually.

      The planned LAIV4 study had unique features in its design that previously had not been
      implemented in vaccine safety studies, including: 1) enrolling a substantial proportion of
      children with moderate-severe asthma 2) using digital peak flow meters and 3) collecting
      clinical data through multiple, complementary, measures for 42 days after vaccination. To
      capitalize on progress made during development of the study protocol and associated documents
      and procedures, CISA is proposing to carry out a study at the three sites to assess the
      feasibility of recruiting, enrolling, retaining, and collecting clinical data on children
      5-11 years with persistent asthma of varied levels of severity in an influenza vaccine safety
      study. Findings from this proposed feasibility study will facilitate improving the LAIV4
      study in the future if it goes forward through the CISA Project or in another venue. In
      2016-2017 season, FDA approved a new influenza vaccine for use in persons aged 4 years and
      older, Flucelvax® Quadrivalent (ccIIV4); ACIP incorporated this vaccine into its
      recommendations for the 2016-2017 influenza season. Therefore ccIIV4 will be used in place of
      LAIV4 for this feasibility study. There is no evidence that Flucelvax® increases the risk of
      wheezing in asthmatic children. The feasibility study also offers an opportunity to gain some
      additional descriptive safety data for this new vaccine in asthmatic children.
    

Intervention name(s): ccIIV4; IIV4
Intervention type(s): Drug; Drug
Other intervention name(s): Flucelvax; Fluarix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other