Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Influenza

Treatments: Other: Vaccine safety surveillance

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02567721

202055

Details and patient eligibility

About

The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.

Full description

Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine. This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.

Enrollment: 11,530 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.
• Pregnant women are also included in this study.

Exclusion criteria

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

Trial design

11,530 participants in 1 patient group

Study Cohort

Description:

Subjects who will receive influenza vaccination between 1 September 2015 and 30 November 2015 in the 9 GP practices from who clinical data routinely collected as part of clinical consultations in primary care will be extracted.

Treatment:

Other: Vaccine safety surveillance