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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
276
Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season
Imperial College London / Imperial College Healthcare NHS Trust
London, United Kingdom
Vaccine Efficacy
Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls
Time frame: During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months
Immune Response to LAIV
To assess the immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures (haemagglutination inhibition titre to specific influenza strain) ii. change in specific nasal IgA responses
Time frame: Up to 6 weeks following administration of a single dose of LAIV
Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV
Incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses: * AEs occurring up to 72 hours after LAIV in participants with a history of atopy / asthma / recurrent wheezing, compared to non-atopic participants. * Wheezing / asthma symptoms in subjects given LAIV who have a past medical history of asthma or recurrent wheeze in the 4 weeks prior to vaccine administration vs the 3-4 week period after LAIV. NB: AE data was NOT collected in household controls, as per protocol NB: AE delay not collected in Controls (as per protocol)
Time frame: Up to 1 month after LAIV administration
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