Swine flu vaccination study extended to children

February 9th, 2010

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 http://www.safetys … ineflu.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 http://www.safetys … ineflu.co.uk

Provided by University of Dundee