Seqirus EPSS 2017

• Research type

  Research Study

• Full title

  Enhanced Passive Safety Surveillance of Seqirus Seasonal Trivalent Influenza Vaccine

• IRAS ID

  231950

• Contact name

  James Larcombe

• Contact email

  james.larcombe@nhs.net

• Sponsor organisation

  Seqirus

• Clinicaltrials.gov Identifier

  PRIM 34782, NIHR

• Duration of Study in the UK

  0 years, 4 months, 0 days

• Research summary

  This study is an Enhanced Passive Surveillance Study (EPSS). It will be conducted in routine clinical care setting where influenza vaccination with Enzira® / generic Seqirus influenza vaccine is expected to be administered in accordance with the product labelling (indication) and applicable policies in the UK.

  This study is also being carried out in Italy with the seasonal trivalent influenza vaccines Agrippal® and Fluad®. The Italian study will have no bearing on the UK study.

  This study will be implemented through the primary care research network of the National Institute for Health Research in the United Kingdom.

  People who have, or are just about to be, routinely vaccinated with Enzira® / generic Seqirus influenza vaccine will be given a uniquely numbered vaccination card containing a phone number. Study participants will be asked to report adverse events occurring within seven days after vaccination.

  The rates of adverse events after vaccination in the overall cohort, and in pre-specified age subgroups of the cohort will be described.

  The main objective of this EPSS is to enhance early detection of a potential change in the known or established immunological reaction of Enzira® / generic Seqirus influenza vaccine. This will especially be compared with the previous influenza season (vaccine composition), in the earliest possible vaccinated cohort in this vaccine season by near-real-time estimation of vaccine exposure and furthering spontaneous adverse events reporting.

  Exposure data is the information collected per administered vaccine and includes:

  • Vaccine brand (Enzira®/generic Seqirus influenza vaccine for the UK
  • Batch number of the vaccine
  • Date of vaccination
  • Age of person vaccinated

  Each patient will be given a unique vaccination card which is linked to the exposure data collected for their particular vaccine.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  17/LO/1437

• Date of REC Opinion

  17 Aug 2017

• REC opinion

  Favourable Opinion