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The Drug Safety Research Unit (DSRU) is an independent academic unit internationally respected for its work in Pharmacovigilance, Pharmacoepidemiology, Risk Management and Training for over 30 years.
In partnership with doctors in England, the DSRU, led by Director Professor Saad Shakir, aims to protect patients in primary and specialist care from unwanted adverse effects of newly marketed medicines using our unique methods of monitoring patients during the lifecycle of medicines.
DSRU is conducting a short term safety study on Fluenz Tetra, the nasal vaccine against seasonal influenza. The first patients have registered to take part in the study following vaccination at the start of October. Under the Department of Health's Flu Plan for 2014, all children aged 2-4 years will receive the Fluenz Tetra vaccine at their GP surgery. Some school age children up to 17 years old will receive the vaccine as part of school pilot projects in selected areas of England. Some children aged over 4 may also receive the vaccine at the GP surgery if they have underlying health issues, such as asthma.
The study is being conducted to satisfy EU guidelines which require enhanced safety surveillance of flu vaccines early in the vaccination season, in order to rapidly detect any significant increase in the incidence of the frequency or severity of expected reactions to the vaccine. In accordance with the EU guidance, we aim to recruit at least 300 children to the study from some of the earliest vaccination clinics at both GP surgeries and primary and secondary schools. Children vaccinated in the surgeries and schools chosen for the study will receive a study pack which includes study information for the child's parent and an informed consent form. If the parent decides to register the child for the study after reading the study information, they will return the consent form to the DSRU. We ask that parents complete a questionnaire 14 days after vaccination of their child in which they provide information on any specific reactions suffered by the child. Further information is available on the study website: www.fluvaccinefeedback.orgView our latest news