Media

Enrolment nearing completion in swine flu vaccine study

20 October 2009

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.

For more information, please contact the Press Office, University of Oxford on 01865 280530 or press.office@admin.ox.ac.uk.
Please note: No opportunities for photographs or filming can be provided on 24 and 25 October. The priority of the Oxford Vaccine Group has to be to carry out the trial.

Notes to Editors

  • 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. 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.
  • Around 1000 children aged between 6 months and 12 years are being enrolled at five centres across the south of England, in the study conducted by Oxford University, Bristol’s Children’s Vaccine Centre, St Georges Vaccine Institute, the University of Southampton Wellcome Trust Clinical Research Facility and the Royal Devon and Exeter NHS Foundation Trust in collaboration with the Health Protection Agency.
  • 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 will be offered to at-risk groups in the UK later this month.
  • Results of the study when complete later this autumn will be reported to the Department of Health.
  • 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 study is being funded by the National Institute for Health Research and has been adopted by the Medicines for Children Research Network.
  • Children who take part in the study would receive two doses of a swine flu vaccine three weeks apart. A blood test would be taken (using a local anaesthetic cream) before and after the immunisation course to check their response to the vaccines.
  • Oxford University’s Medical Sciences Division is one of the largest biomedical research centres in Europe. It represents almost one-third of Oxford University’s income and expenditure, and two-thirds of its external research income. Oxford’s world-renowned global health programme is a leader in the fight against infectious diseases (such as malaria, HIV/AIDS, tuberculosis and avian flu) and other prevalent diseases (such as cancer, stroke, heart disease and diabetes). Key to its success is a long-standing network of dedicated Wellcome Trust-funded research units in Asia (Thailand, Laos and Vietnam) and Kenya, and work at the MRC Unit in The Gambia. Long-term studies of patients around the world are supported by basic science at Oxford and have led to many exciting developments, including potential vaccines for tuberculosis, malaria and HIV, which are in clinical trials.