Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18

This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.

This is the third pilot study following, EPI-FLU-045 VS UK [NCT02567721] and EPI-FLU-046 VS UK [NCT02893878] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.

Inclusion Criteria:

• All individuals who receive influenza vaccination among the 10 participating GP practices between 1 September and 30 November 2017 are eligible for inclusion in the analysis.

Exclusion Criteria:

• Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.