Flu vaccine study
Research type
Research Study
Full title
A Postmarketing Non-interventional Cohort Study of the Safety of Live Attenuated Influenza Vaccine (LAIV) in Subjects 2 Through 17 Years of Age
IRAS ID
158382
Contact name
Saad Shakir
Contact email
Sponsor organisation
Drug Safety Research Unit
Research summary
This is a post authorisation safety non-interventional cohort study on the live-attenuated nasal influenza vaccine, Fluenz Tetra®. The aim of the study is to rapidly detect changes in the frequency or severity of reactions to the vaccination in children during the 2014/2015 influenza season. The study is being conducted to satisfy the European Medicines Agency's (EMA)requirement for enhanced safety surveillance for seasonal influenza vaccines in the EU. Children will be provided with study packs including a consent form following vaccination for completion by their parents. Consented patients or their parents will be asked to report any adverse events that occur via a dedicated website within 14 days of receiving the vaccination. Serious adverse events will be followed up with the patient's GP if consent for this is given. A report for the EMA will be written 4 weeks after the first vaccination.
REC name
West of Scotland REC 5
REC reference
14/WS/1067
Date of REC Opinion
7 Aug 2014
REC opinion
Favourable Opinion