Conditions: Influenza Vaccines Efficacy and Safety
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 276
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness. arm 2: Surveillance in siblings of participants in the Intervention arm, through nasal swabbing in the event of influenza-like illness, irrespective of their vaccination status.

Interventions: intervention 1: Live attenuated influenza vaccine intervention 2: Surveillance (nasal swabbing) during influenza season
Intervention descriptions: intervention 1: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season intervention 2: None

Protocol document: