Enrolment nearing completion in swine flu vaccine study

Enrolment nearing completion in swine flu vaccine study

22 October 2009

Enrolment in South London is almost complete in a study of the use of two swine flu vaccines in children, the team leading the London arm of the UK-wide study has announced.

The Vaccine Institute at St George’s, University of London hoped to involve 250 children and their parents in London in this study; half the children aged between six months and three years and the other half from three to 12 years old. Over 120 children are already participating with others booked to join on the 24 and 26 of October.

By conducting this study, the researchers hope to determine if one of the vaccines is better tolerated or more likely to protect against swine flu in this age group than the other. The overall aim is to help the Department of Health provide the most effective protection against swine flu.

The London lead investigator and specialist in paediatric infectious disease, Dr Paul Heath said: “The findings from this study will help inform decisions about which vaccine will be best for protecting children, who are one of the age groups most vulnerable to swine flu.

“The response from the local community has been unprecedented for this type of study in such a small timescale, and I’d like to express my thanks to all those families who have wanted to take part.”

Across the five study sites participating in this research – Oxford, Southampton, Bristol, Exeter and St George’s – 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 1,000 children are involved in the whole study, the St George’s, University of London group are asking the parents of children of between six months and 12 years, and especially those with children under three, who would like to register their interest to still go to the study website at www.swineflutrial.org for further information.

“An even greater number of children involved in the study will add strength to the overall findings,” explains Dr Heath.

Enrolment began on 23 September and the first children were vaccinated at the St George’s Vaccine Institute on 1 October. The St George’s team is hoping to get any other parents and children involved in time to give vaccinations on Saturday 24 and Monday 26 October.

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For more information, please contact Helena Clay in the Press Office at St George’s, University of London on 020 8266 6831 or helena.clay@sgul.ac.uk

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 1,000 children aged between six 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 George’s, University of London’s 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.

* Full project details can be found on the National Institute for Health Research’s website at: http://www.nihr.ac.uk/news/Lists/News/DispForm.aspx?ID=960
* The St George's Vaccine Institute is an independent, non-commercial, academic institution, which is part of St George’s, University of London. It opened in 1996 as a combined clinical, scientific and educational facility.  The Institute predominantly focuses on protecting against paediatric infections as well as diseases of poverty that afflict populations in under-developed and resource-poor areas. It conducts human clinical trials of paediatric vaccines and of vaccines against infectious diseases plaguing some of the most underprivileged members of the world community.