Swine Flu (Novel Influenza A H1N1) Vaccine Study
Research type
Research Study
Full title
Open Label, Randomized, Parallel-Group, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 vaccine and GlaxoSmithKline H1N1 vaccine in children 6 months to 12 years of age
IRAS ID
29927
Sponsor organisation
University of Oxford
Eudract number
2009-014719-11
ISRCTN Number
n/a
Research summary
In the first half of this year a novel flunza A H1N1 virus has resulted in an flunza 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 flunza pandemic two vaccine manufacturers, Baxter and GlaxoSmithKline, have gained marketing authorisation approval from the European Medicines Agency (EMEA) for a pandemic strain vaccine under the ??mock-up? dossier route based on limited clinical trial data for a candidate H5N1 vaccine. This ??mock-up? dossier route for pandemic flunza vaccines allows the submission of a core pandemic dossier during the interpandemic period, which results in the approval of a mock-up 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 flunza A H1N1 strain.Given the high rates of swinfludisease in children, this age group is likely to particularly benefit from immunisation against this virus, however there are few data on the use of these vaccines in a paediatric 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.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
09/H0604/107
Date of REC Opinion
18 Sep 2009
REC opinion
Further Information Favourable Opinion