FLU07E-Enhanced passive safety surveillance of Vaxigrip and Intanza 15
Research type
Research Study
Full title
Enhanced passive safety surveillance of VAXIGRIP® (trivalent inactivated split virion influenza vaccine, IM route) and INTANZA® 15µg (trivalent inactivated split virion influenza vaccine, ID route) vaccines in Europe during the influenza season 2015/16
IRAS ID
185798
Contact name
Tim Caroe
Contact email
Sponsor organisation
Sanofi Pasteur MSD SNC
Duration of Study in the UK
0 years, 2 months, 31 days
Research summary
This is enhanced passive safety surveillance of VAXIGRIP® and INTANZA® 15μg vaccines in Europe during the influenza season 2015/16. The study is funded by Sanofi Pasteur MSD SNC.
This surveillance is being implemented in order to address the European Medicines Agency (EMA) requirement described in the “Interim guidance on enhanced safety surveillance for seasonal influenza vaccine in Europe” issued by the Pharmacovigilance Risk Assessment Committee (PRAC) in April 2014.
As influenza vaccination is a mass immunisation in a relatively short period of time, a dedicated system for influenza vaccines needs to be put in place to rapidly evaluate that the safety profile of this seasonal vaccine is similiar to the one of the previous season. The aim is to mitigate risks before the peak period of seasonal immunisation (i.e. at least within the first month after the start of immunisation).
To achieve this goal, a sample of 1000 vaccinees for VAXIGRIP® and 1000 vaccinees for INTANZA® 15µg in the UK and in Finland is asked to participate in this surveillance and report to a dedicated toll-free number any side effect occurring within 7 days after vaccination.
In the UK 14 sites will participate and will contribute to the distribution of SRCs to 1400 patients who will receive INTANZA® 15μg (1000 patients aged 60 years and older) or VAXIGRIP® (400 patients aged 6 months to 2 years and from 18 years and older).
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0338
Date of REC Opinion
25 Aug 2015
REC opinion
Favourable Opinion