Status:
COMPLETED
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
University of Surrey
Conditions:
Influenza, Human
Eligibility:
All Genders
6+ years
Brief Summary
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 interes...
Detailed 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). Thi...
Eligibility Criteria
Inclusion
- 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
- Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Key Trial Info
Start Date :
September 12 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
23939 Patients enrolled
Trial Details
Trial ID
NCT03278067
Start Date
September 12 2017
End Date
November 30 2017
Last Update
January 13 2020
Active Locations (1)
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1
GSK Investigational Site
Surrey, United Kingdom, GU2 7XH