Project Details

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You can view the full text from the H1N1 influenza and pandemic flu themed issue 1 publication details page on the HTA website

In order to help combat the efffect of the new swine flu virus that has emerged in recent months, the UK government has placed orders with two manufacturers to supply sufficient vaccine for the key population groups. The two vaccines were originally developed for a different strain of flu virus (the so called bird flu strain ) that was thought to be the most likely cause of the next global epidemic. However, there is no reason to suppose that they won't be just a suitable for the swine flu strain. None of the studies that has been or will be conducted by the two manufacturers on the old bird flu or new swine flu vaccines have compared the two products in a head-to-head study. Therefore it is difficult to know which of the two swine flu vaccines might be better to use in children or whether they are just as good as each other. Children have been identified as a key vulnerable group for prioritisation when the first supplies of vaccine become available in the UK. As initial supplies of vaccine will be limited it is important that we use them to greatest effect. Since the two vaccines purchased for the UK differ in how they are made it may be that one works much better than the other in children . The only way to answer this question is to make a direct comparison between the vaccines by deciding randomly (eg by flicking a coin) which child receives which vaccine.

The results of this research will be of immediate use to the health experts advising the UK government on which groups in the population should receive swine flu vaccination, and also which vaccine is best to use in children.

The team of doctors and nurses who will be carrying out this research are all highly experienced in these type of vaccine studies in children. They will be working together in different parts of the country to make sure that this study is completed as soon as possible as this information is urgently needed to inform UK vaccine policy. Despite the urgency, all the usual safeguards that are required for such studies in children will be put in place and all the study procedures will be vetted by an independent ethics committee.

To compare the immunogenicity in children aged 6 months to 12 years of age of a two dose course of the Baxter and GSK H1N1 vaccines.

To compare local and systemic symptoms in children aged 6 months to 12 years of age after each dose of the Baxter and GSK H1N1 vaccines