Health

22 Oct 09

Enrolment in Oxfordshire is almost complete for a study of the use of two swine flu vaccines in children, the University of Oxford team leading the UK-wide study has announced.

The Oxford Vaccine Group at Oxford University hoped to involve 250 children and their parents in Oxfordshire in this study; half the children aged between 6 months and 3 years and the other half from 3 to 12 years old. Over 180 children are already participating and another 70 have appointments booked ready to join on the weekend of 24 and 25 October.

Chief Investigator Professor Andrew Pollard said: ‘There has been an unprecedented response by Oxfordshire parents and their children. It is unparalleled for any clinical trial in children I am aware of, and I’d like to express my thanks to all those families who have wanted to take part.’

Across the five study sites – Oxford, Southampton, Bristol, Exeter and St George’s in South London – over 600 children have received their first vaccination as part of this trial and a further 200 have appointments booked.

So that a final total of around 1000 children are involved in the whole study, the Oxford Vaccine Group are asking the parents of children under three who would like to register their interest to still go to the study website at www.swineflutrial.org for further information. With more children of this age involved, the power of the study to give clear results will be improved.

Enrolment began on 23 September and the first children were vaccinated at the Children’s Hospital in Oxford on 26 September. The Oxford Vaccine Group are hoping to get any other parents and children involved in time to give vaccinations this weekend, 24 and 25 October.

The study is a head-to-head comparison of two swine flu vaccines in children to gain important information about their most effective use in children. The vaccines, made by GSK and Baxter, are the ones the Department of Health has purchased to control an expected second wave of swine flu in the UK this autumn and winter.

Children are one of the age groups most vulnerable to swine flu infection, so it is vital that more information is obtained on their response to these vaccines. The results should help determine if one of the vaccines is better tolerated or more likely to protect against swine flu than the other in this age group. The study will help in decisions by the Department of Health about which vaccine will be best for protecting children.

Children who take part in the study receive two doses of a swine flu vaccine three weeks apart. A blood test is taken (using a local anaesthetic cream) before and after the immunisation course to check their response to the vaccines.

Previous safety trials of these and similar vaccines elsewhere have not shown any safety concerns. Any side effects of the vaccines are expected to be similar to normal seasonal flu vaccines, and might include mild tenderness at the injection site or a short-lived fever. Both vaccines have now been licensed and are beginning to be offered to at-risk groups in the UK.

Results of the study when complete later this autumn will be reported to the Department of Health.