Swine Flu (Novel Influenza A H1N1) Vaccine Study
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza
      pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest
      rates of disease are being seen in young children. In anticipation of an influenza pandemic
      two vaccine manufacturers, Baxter and GlaxoSmithKline, have gained marketing authorization
      approval from the European Medicines Agency (EMEA) for a pandemic strain vaccine under the
      "mockup" dossier route based on limited clinical trial data for a candidate H5N1 vaccine.
      This "mockup" dossier route for pandemic influenza vaccines allows the submission of a core
      pandemic dossier during the interpandemic period, which results in the approval of a mockup
      pandemic vaccine. This is followed by a fast track approval of the pandemic vaccine based on
      the submission of the pandemic variation when the situation arises. The Baxter and
      GlaxoSmithKline vaccines have now been modified to cover the novel influenza A H1N1 strain.

      Given the high rates of swine flu disease in children, this age group is likely to
      particularly benefit from immunization against this virus, however there are few data on the
      use of these vaccines in a pediatric population. The proposed study therefore aims to assess
      the immunogenicity, safety, and tolerability of these two H1N1 vaccines when administered as
      two doses three weeks apart to children aged 6 months to 12 years of age.
    

Detailed description: 
      The study will be an open label, randomised, parallel group, multicentre clinical trial
      conducted by a consortium of the leading paediatric vaccine research units in the United
      Kingdom. The study will recruit healthy children 6 months to 12 years of age. Children with
      previously laboratory confirmed infection with swine flu will be excluded, as will those that
      have received a treatment course of oseltamivir. Children with immune deficiencies and egg
      allergy will also be excluded.

      The study will be conducted as a collaboration between the Health Protection Agency and the
      following study recruitment sites: Oxford Vaccine Group (OVG), Bristol Children's Vaccine
      Centre (BCVC), the Royal Devon and Exeter Hospital, St George's Vaccine Institute (SGVI) and
      the University of Southampton Wellcome Trust Clinical Research Facility (USWTCRF). Families
      in the area of these research sites will be notified of the study by methods including print
      and electronic media, posters and direct mail out via the child health computer departments.
      The study visits themselves will be conducted in locations such as hospital outpatients, GP
      surgeries, or schools. General practitioners will be informed of the study and all
      immunisations administered during the study, as will the relevant child health computer
      department.

      Participants will be randomised on 1:1 basis to receive 2 doses of either of the H1N1
      influenza vaccines being studied. These vaccines will be given 2-3 weeks apart and the blood
      tests will be taken at baseline and around 3 weeks after completion of the 2 dose
      immunisation course. If at the start of the trial there is clinical data or a recommendation
      from JCVI that supports the use of a half dose of either vaccine in children under 3 years of
      age, this will be used for this age group and the ethics committee will be informed of this
      change.

      Participants' families will be given diary cards to record local and systemic reactions to
      the vaccines administered, as well as recording daily temperatures for the 7 days after
      receipt of the vaccines. They will be telephoned 5-7 days after each vaccination to determine
      if there have been any SAEs since vaccination and to remind them to mail their completed
      diary cards to the HPA. Participants' families will also receive a memory card on which to
      record any visits to a doctor or emergency department from the 8th day after vaccine
      administration to the next study visit and any adverse events recorded in the diary card that
      are ongoing after day 7.

      There will be 4 groups of children in the study:

      Group A1: Children aged 6 months to less than 3 years of age will receive 2 doses of the
      Baxter H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3
      weeks after the second vaccine dose.

      Group B1: Children aged 6 months to less than 3 years of age will receive 2 doses of the GSK
      H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks
      after the second vaccine dose.

      Group A2: Children aged greater than 3 years of age to 12 years of age will receive 2 doses
      of the Baxter H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and
      around 3 weeks after the second vaccine dose.

      Group B2: Children aged greater than 3 years of age to 12 years of age will receive 2 doses
      of the GSK H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around
      3 weeks after the second vaccine dose.
    

Intervention name(s): Baxter Novel Influenza A H1N1 Whole Virus Vaccine; GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Two 0.5 ml doses of vaccine given within 3 weeks interval; Two 0.25 ml doses of vaccine given within 3 weeks interval
Other intervention name(s): Celvapan; Pandemrix
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Flu vaccine; H1N1 swine flu virus; Immunogenicity; Reactogenicity