Efficacy & Safety of Nasal Influenza Immunisation in Children
Condition: Influenza Vaccines Efficacy and Safety
MeSH terms: Influenza, Human
Intervention: Live attenuated influenza vaccine; Surveillance (nasal swabbing) during influenza season
Intervention description: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The UK Departments of Health now recommend annual influenza vaccination for all children 2-7
      years of age, with children over 7 years eligible for vaccination if in certain higher risk
      clinical categories. Though data are available documenting the safety and immunogenicity of
      LAIV in this age group, there are little data to assess efficacy and immune correlates in UK
      children, and in particular atopic children. This study will enrol 200 children (and at least
      200 unvaccinated household sibling controls), many with a history of asthma or recurrent
      wheezing, and allow an assessment of efficacy, safety and immune correlates in these
      children, and how this varies with prior administration of pandemic influenza vaccine and/or
      LAIV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 2 - 18 years old

          -  Written informed consent from parent/guardian (or patient themselves from age 16
             years), with assent from children aged 8 years and above wherever possible.

        Exclusion Criteria:

          -  Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace
             residue) [notwithstanding allergy to egg protein]

          -  Previous systemic allergic reaction to LAIV

          -  Previous allergic reaction to an influenza vaccine (not LAIV) is a relative
             contra-indication, which must be discussed with the site PI to confirm patient
             suitability

          -  Children/adolescents who are clinically immunodeficient due to conditions or
             immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic
             HIV infection; cellular immune deficiencies; and high-dose corticosteroids**.

             **High-dose steroids is defined as a treatment course for at least one month,
             equivalent to a dose of prednisolone at 20mg or more per day (any age); or for
             children under 20kg, a dose of 1mg/kg/day or more.

          -  Children and adolescents younger than 18 years of age receiving salicylate therapy
             because of the association of Reye's syndrome with salicylates and wild-type influenza
             infection.

          -  pregnancy

          -  Febrile ≥ 38.0 'C in last 72 hours

          -  Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for
             regular use by the child's treating healthcare professional

          -  Recent admission to hospital in last 2 weeks for acute asthma

          -  Current oral steroid for asthma exacerbation or course completed within last 2 weeks

          -  Received any blood or blood products within the past 12 weeks

          -  Any other significant condition or circumstance which, in the opinion of the
             investigator, may either put the participant at risk because of participation in the
             study, or may influence the result of the study, or the participant's ability to
             participate in the study.