9 February 2010

Swine flu vaccination study extended to children

A study being run in Scotland to identify any rare side effects of the swine flu vaccine has now been expanded to include under-16s.

The study, which was launched by the University of Dundee in November, aims to identify any rare side effects of the swine flu vaccination, which has been administered to thousands of people across the country. Safety studies have already been carried out on the vaccine as part of the licensing process, and these have shown the vaccine to be safe. However, follow-up of large numbers of people can identify any very rare side effects of the vaccine that cannot normally be identified through routine clinical trials.

Thousands of people have received the swine flu vaccination in Scotland as part of the vaccination programme. High risk patient groups and health care workers were targeted first. Now, the vaccine is also being offered to young children.

Dr Isla Mackenzie, consultant physician with the Medicines Monitoring Unit at the University of Dundee and lead doctor on the study, said, 'We have had a good response already with thousands of adults registering to take part in the study. We also had a lot of interest from parents wanting to register their younger children for the study. We therefore decided to get the necessary approvals from the ethics committee and regulatory authorities , so now children under-16 can also take part.'

'The vaccination programme for under-5 year olds (and over 6 months old) is running at the moment throughout Scotland. Using online technology, parents can register their children for the study easily by going to our website.'

The study is being run by the Medicines Monitoring Unit (MEMO), University of Dundee, in collaboration with the Drug Safety Research Unit (DSRU), Southampton.

The study organisers hope that more adults and children from all over Scotland will join the study. The study uses internet and mobile phone technology to streamline the data collection and processing as much as possible.

Patients are given a questionnaire after they have been vaccinated. They will then be followed up for a year after their swine flu vaccination to monitor for any rare side effects.

Follow-up can be carried out by a simple monthly email message in most cases, or by text message, telephone or post if preferred. People who were offered swine flu vaccination but decided not to accept it can also take part in the study by enrolling for the follow-up process. Parents who decided against their child being vaccinated can do the same. This will allow comparison to be drawn between people who had the vaccine and those who didn’t.

Registration can be done online at www.safetyswineflu.co.uk; or by phoning 0800 9173509. Parents of children aged 10 and under can register their children for the study while older children can decide whether they would like to take part.

Professor Tom MacDonald, of MEMO added, 'We are proud to be running this study in Scotland. It allows us to collect important data but also to use technology to pilot new ways of collecting information. This makes it easier for the people taking part and it is more economical. This allows an academic unit such as ours to perform this type of research with limited funding.'

Funding for the study has come internally from the University.

More information is available at www.safetyswineflu.co.uk.

NOTES TO EDITORS

The UK government has initiated a programme of vaccination in response to an outbreak of H1N1 influenza A viral infection (swine flu). Recently, the target groups for swine flu vaccination were extended to include children between 6 months and up to 5 years old. Monitoring in large numbers of people who have received the vaccination will enable the identification of any very rare side effects from the vaccination.

A number of studies are being conducted in the UK to monitor the vaccine and the epidemiology of swine flu. This proposal is complementary to these initiatives. The study is being conducted by the University of Dundee (www.dundee.ac.uk), in partnership with the Drug Safety Research Unit (www.dsru.org). The study aims to collect data from as many people as possible who were offered the swine flu vaccine. They will each be followed up over a one-year period. This number is needed to allow adequate appraisal of rare adverse events which may only occur in 1/10,000 people.

The study will be conducted as follows:

• The study will be publicised (using posters and leaflets) within GP surgeries to patients visiting their GPs. Patients who wish to participate (whether vaccinated or not) will provide their consent and some very basic information on their demography, current health status, date of vaccination (if vaccinated) and contact details of next of kin.
• Information technologies (Internet and mobile phones) will be used to collect data from patients or their next of kin on simple outcomes (an event causing admission to hospital, receipt of emergency treatment, pregnancy) to examine the feasibility of near real-time vaccine monitoring.

The Medicines Monitoring Unit (MEMO), University of Dundee is an academic centre studying drug use and side effects.

The Drug Safety Research Unit in Southampton is a registered independent medical research charity that works in association with the University of Portsmouth. The Unit was established to provide a monitoring system to safeguard public health following the introduction of new medicines.

For media enquiries contact:
Roddy Isles
Head, Press Office
University of Dundee
Nethergate, Dundee, DD1 4HN
TEL: 01382 384910
E-MAIL: r.isles@dundee.ac.uk
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