Fluenz Tetra Enhanced Safety Surveillance Programme 2018-2019
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 Influenza Season in England (2018-2019)
IRAS ID
249070
Contact name
Elizabeth Lynn
Contact email
Sponsor organisation
DSRU Education and Research Ltd
Duration of Study in the UK
0 years, 3 months, 10 days
Research summary
Children (or their parents/guardians) can participate in this safety surveillance if they have received the nasal seasonal flu vaccine, Fluent Tetra, as part of their routine care in participating GP practices or schools.
After vaccination, immunisation staff will provide parents (or guardians) with a ‘Safety Report Card’ (SRC) and an Information Sheet explaining the purpose of the surveillance. Parents are requested to return the card to the vaccine manufacturer (AstraZeneca) if their child has any side effects after vaccination. The card asks about the symptoms experienced and whether the child has any medical conditions or takes medication.
Participation in the surveillance is voluntary. Parents must sign the card to show they have read and understood the Information Sheet. They are 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 card themselves.
Details from the cards will be entered into the AstraZeneca safety database. Personal identifiers (names, addresses) will only be visible to authorised personnel in the UK. DSRU Education and Research will help to analyse the data collected but will only have access to anonymised information.
This is not a clinical trial. Children will not be given any experimental treatments or require any additional clinical assessments as part of this surveillance. Their care will be unaffected by the decision to take part.
Immunisation providers will receive a fee to cover costs. Their staff will be asked to prepare cards with the vaccination date and batch number before issue and provide weekly figures on the numbers of children given cards. The research team will look for any differences in reporting of side effects between different age groups, batch numbers and flu seasons.REC name
London - Bromley Research Ethics Committee
REC reference
18/LO/1414
Date of REC Opinion
5 Oct 2018
REC opinion
Further Information Favourable Opinion