Passive Fluenz Tetra Safety Surveillance
Research type
Research Study
Full title
Passive Enhanced Safety Surveillance (ESS) of the Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during the early 2015/2016 Influenza Season in England
IRAS ID
183946
Contact name
Saad Shakir
Contact email
Sponsor organisation
Drug Safety Research Unit
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
This is a passive enhanced safety surveillance (ESS) project on the live-attenuated nasal influenza vaccine, Fluenz Tetra®. The aim of the surveillance is to rapidly detect changes in the frequency or severity of reactions to the vaccination in children during the 2015/2016 influenza season. The surveillance 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 a Safety Report Card with an integrated consent form following vaccination for completion by their parents in the event that any suspected side effects are experienced. Any data received will be collated and analysed and a report for the EMA will be written 6 weeks after the first vaccination.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0656
Date of REC Opinion
17 Aug 2015
REC opinion
Further Information Favourable Opinion