FLU08E ­Enhanced passive safety surveillance of Vaxigrip and Intanza15

• 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 2016/17

• IRAS ID

  209935

• Contact name

  Tim Caroe

• Contact email

  timcaroe@nhs.net

• Sponsor organisation

  Sanofi Pasteur MSD SNC

• Duration of Study in the UK

  0 years, 3 months, 26 days

• Research summary

  This is an enhanced passive safety surveillance of VAXIGRIP® and INTANZA® 15μg vaccines during the influenza season 2016/17 as funded by Sanofi Pasteur MSD SNC.
  
  This surveillance is being implemented to address a European Medicines Agency (health authorities) requirement concerning all seasonal influenza vaccines and is repeated each year. This is 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
  
  Influenza vaccine helps to protect against influenza (flu). Flu is a disease that is caused by different types of strains that can change every year. Sanofi Pasteur MSD annual influenza vaccine safety profiles are well known and characterised.

  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 similar to the previous season. The aim is to mitigate risks before the peak period of seasonal immunisation.
  
  To achieve this goal, a sample of 1000 vaccinees for VAXIGRIP® and 1000 vaccinees
  for INTANZA® 15µg in the UK and Republic of Ireland is asked to participate in this surveillance and report to a dedicated toll­free number any side effect occurring within 7 days after vaccination.

  In the UK 7 sites will participate and will contribute to the distribution of SRCs to 1500 patients who will receive INTANZA® 15μg (1000 patients aged 60 years and older) or VAXIGRIP® (500 patients aged 6 months to 2 years and from 18 years and older).

• REC name

  London - Brent Research Ethics Committee

• REC reference

  16/LO/1372

• Date of REC Opinion

  22 Jul 2016

• REC opinion

  Favourable Opinion