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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Influenza, Human

Treatments: Other: Enhanced vaccine safety surveillance

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03278067

207781

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23,939 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

23,939 participants in 3 patient groups

Vaccinated_Fluarix Tetra Group

Description:

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

Treatment:

Other: Enhanced vaccine safety surveillance

Vaccinated_Non GSK Group

Description:

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

Treatment:

Other: Enhanced vaccine safety surveillance

Vaccinated_Unknown Group

Description:

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

Treatment:

Other: Enhanced vaccine safety surveillance