Fluenz Tetra Enhanced Safety Surveillance 2016 -17
Research type
Research Study
Full title
Passive Enhanced Safety Surveillance (ESS) of Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during the early 2016/2017 Influenza Season in England
IRAS ID
210509
Contact name
Elizabeth Lynn
Contact email
Sponsor organisation
Drug Safety Research Unit Education & Research Ltd.
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Children (or their parents/guardians) are eligible to participate in this surveillance if they have received the nasal seasonal flu vaccine, Fluenz Tetra, as part of their routine care in accordance with guidance from the Department of Health. \nAfter vaccination, the parent or guardian of children vaccinated in GP surgeries will be given an Information Sheet by immunisation staff, explaining the purpose of the surveillance, and a ‘Safety Report Card’ (SRC). If their child has any side effects, they are requested to complete and return (by freepost) the SRC. The card asks simple questions about symptoms experienced by the child following vaccination and whether the child has any medical conditions or takes medication. For children who receive the vaccination in school, the Information Sheet and SRC will be given to the child immediately after vaccination alongside any other information that they would routinely receive from the school nurse to take home. \nAt GP surgeries and school sites and prior to handing out the SRC, the immunisation team will be asked to record information on the SRC including the vaccination date, the batch number administered and the study site number. \nParticipation in the surveillance study is voluntary. The person completing the SRC is asked to sign the card to show they have read and understood the Information Sheet. They are also asked to provide contact details for themselves and the child’s GP in case the research team need to ask further questions about the symptoms experienced. Children aged 16 and 17 years may complete the SRC themselves. \nAs this is post-marketing surveillance, not a clinical trial, the child will not need to have any additional clinical assessments and their care will be unaffected by the decision to take part. The child will not be given any experimental treatment or medication as part of this surveillance. This safety surveillance is low risk and all sites will be requested to complete the same activities. \nCompleted SRCs will be returned by freepost to the marketing authorisation holder in the UK, AstraZeneca. The details from the cards will be entered into the company’s safety database and will be visible in an anonymised format to authorised personnel in the UK and in other countries. Contact details provided by the person completing the card will be used only if the research team need to ask further questions about the child’s symptoms. AstraZeneca and DSRU Education and Research will analyse and assess the information collected. DSRU Education and Research will have access to the information in an anonymised format only and no contact details will be shared with DSRU Education and Research. If serious suspected adverse reactions are reported in this surveillance this information will be reported (again, in anonymised format only) to the drug regulators (EMA).\nEach vaccination site (school or GP surgery) will be asked to complete a data capture form on a weekly basis to provide details of the number of children that were given an SRC for each different age group and batch number. This allows calculation of the number of reported adverse drug reactions (ADRs) relative to the number of cards issued. The study team will then see if there are any differences between reporting of adverse drug reactions between different age groups or for different batch numbers and will be able to compare the pattern of ADRs with those reported in previous years.\n
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/1369
Date of REC Opinion
22 Jul 2016
REC opinion
Favourable Opinion