A Phase III/IV Open-label Study of the Immunogenicity and Safety of a Single Dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for Each of Three Successive Years in Children naïve to, or in Previous Receipt of the AS03B Adjuvanted H1N1 (2009) Influenza Vaccine (Pandemrix ™).
Condition: Live Attenuated Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The Department of Health has recently announced the implementation of annual vaccination for
      all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is
      delivered as a nasal spray. This study seeks primarily to measure antibody responses to the
      LAIV vaccination over three subsequent years and will involve six blood samples, six dried
      blood spots (taken from the end of the blood sample needle) and six oral fluid samples -
      before and three weeks after each vaccination each year. These samples will allow us to
      assess how the immune system responds to the vaccinations in terms of the antibodies that are
      present.
    

Detailed description: 
      The Department of Health has recently announced the implementation of annual vaccination for
      all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is
      delivered as a nasal spray. The programme will begin in the influenza season, from September
      2013, with children aged 24 years of age, and older children being included from the
      influenza season of 2014. Therefore this study seeks primarily to measure antibody responses
      to the LAIV vaccination over three subsequent years and will involve six blood samples, six
      dried blood spots (taken from the end of the blood sample needle) and six oral fluid samples
      - before and three weeks after each vaccination each year. These samples will allow us to
      assess how the immune system responds to the vaccinations in terms of the antibodies that are
      present.

      The study will specifically recruit children in previous receipt of Pandemrix, a pandemic
      influenza vaccine, and those naïve to pandemic influenza vaccination, which will allow the
      comparison of responses to LAIV between these groups.

      The sample size required to answer the primary objective of the study is 200 evaluable
      children per group. As the study will be conducted over three years the recruitment target
      will be 500 children across the two groups to allow for the expected attrition of numbers
      over time.

      The investigators will also be assessing how well the vaccines are tolerated and each
      participant will therefore be asked to complete a health diary for the week following
      vaccination. They will be asked to record any symptoms, which the investigators will elicit
      in line with the information in the Summary of Product Characteristics (SPC) as well as any
      illnesses or visits to their GP or hospital.
    

Intervention name(s): Fluenz
Intervention type(s): Drug
Intervention description(s): Live attenuated influenza vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Live attenuated influenza vaccine; fluenz; pandemrix; pandemic influenza vaccine; immunogenicity