Seqirus EPSS 2016

• Research type

  Research Study

• Full title

  Enhanced Passive Safety Surveillance of the Seasonal Trivalent Influenza Vaccine (Enzira® / generic Seqirus influenza vaccine) for the 2016-17 influenza season

• IRAS ID

  212133

• Contact name

  James Larcombe

• Contact email

  james.larcombe@nhs.net

• Sponsor organisation

  Seqirus

• Clinicaltrials.gov Identifier

  PRIM 30538, NIHR

• Duration of Study in the UK

  0 years, 4 months, 31 days

• Research summary

  This study is an observation study and 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 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 eight 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.
  Pregnant and immunocompromised participants, and children aged less than 5 are not excluded from this study if they have been vaccinated.
  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)
  • 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

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  16/NE/0275

• Date of REC Opinion

  10 Aug 2016

• REC opinion

  Favourable Opinion