Safety of Nasal Influenza Immunisation in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Administration of Live attenuated influenza vaccine (LAIV)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 479.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been
      approved by a number of licensing boards and is given by a spray into the nose. In the United
      Kingdom (UK), the vaccine has been demonstrated to be highly effective against influenza
      infection. Further, despite concerns that LAIV can cause wheezing in children under age 2
      years, the previous SNIFFLE studies have demonstrated it to be safe in children over 2 years
      with mild-moderate asthma.

      The objective of this multicentre study is to further assess the safety of intranasal LAIV in
      children with asthma and recurrent wheeze, including those with severe symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 2 - 18 years old (inclusive)

          -  Physician diagnosis of asthma or recurrent wheezing (by the hospital specialist) AND
             (i) in children age 2-4 years: ≥2 exacerbations in the past year requiring oral
             steroids or observation in-hospital beyond 4 hours duration, OR (ii) in children ≥ 5
             years of age, receiving treatment equivalent to at least BTS/SIGN step 2 therapy.

          -  Written informed consent from parent/guardian (or the patient themselves from age 16
             years), with assent from children aged 8 years and above wherever possible.

        Exclusion Criteria:

          1. Admission to Paediatric Intensive Care for invasive ventilation due to a respiratory
             illness in the preceding 2 years.

          2. Contraindications to LAIV (notwithstanding allergy to egg protein), which include:

               1. Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible
                  trace residue)

               2. Previous systemic allergic reaction to LAIV

               3. 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

               4. 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 greater than 20mg prednisolone per day (any age), or for
                  children under 20kg, a dose greater than 1mg/kg/day.

                  NB: LAIV is not contraindicated for use in individuals with asymptomatic HIV
                  infection; or individuals who are receiving topical/inhaled/low-dose oral
                  systemic corticosteroids or those receiving corticosteroids as replacement
                  therapy, e.g. for adrenal insufficiency.

               5. 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.

               6. pregnancy

          3. Contraindications to vaccination on that occasion, e.g. due to child being acutely
             unwell:

               1. Febrile ≥38.0 degrees C in last 72 hours

               2. *Acute wheeze in last 72 hours requiring treatment beyond that normally
                  prescribed for regular use by the child's treating healthcare professional

               3. *Recent admission to hospital in last 2 weeks for acute asthma

               4. *Current oral steroid for asthma exacerbation or course completed within last 2
                  weeks

               5. 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.

                    -  Items 3b-3d are relative contra-indications: Many children with
                       "difficult-to-control" symptoms may meet fail to meet these criteria on a
                       routine basis. Where these are present, the study centre PIs are able to
                       authorise participation on a case-by-case basis, after assessing the child
                       and their lung function at the time of enrolment.