Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Influenza, Human

Treatments: Other: Vaccine safety surveillance

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02893878

202056

Details and patient eligibility

About

The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.

Enrollment: 19,334 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Volunteers receiving an influenza vaccine and receiving an ADR card at the beginning of the 2016/17 season.

Exclusion criteria

• In the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

Trial design

19,334 participants in 3 patient groups

Vaccinated_Fluarix Tetra Group

Description:

Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in approximately 10 volunteer practices.

Treatment:

Other: Vaccine safety surveillance

Vaccinated_Non GSK Group

Description:

Volunteered subjects who received Non-GSK influenza vaccination in approximately 10 volunteer practices.

Treatment:

Other: Vaccine safety surveillance

Vaccinated_Unknown Group

Description:

Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in approximately 10 volunteer practices.

Treatment:

Other: Vaccine safety surveillance