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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23939 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-12

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza, Human

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaccinated_Fluarix Tetra Group

Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017.

Enhanced vaccine safety surveillance

Intervention Type OTHER

Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.

Vaccinated_Non GSK Group

Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017.

Enhanced vaccine safety surveillance

Intervention Type OTHER

Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.

Vaccinated_Unknown Group

Volunteered subjects who received influenza vaccination (GSK or non-GSK not known) in 10 volunteer GP practices between 01 September and 30 November 2017.

Enhanced vaccine safety surveillance

Intervention Type OTHER

Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.

Interventions

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Enhanced vaccine safety surveillance

Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.

Intervention Type OTHER

Other Intervention Names

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Data collection

Eligibility Criteria

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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.