Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines
NCT ID: NCT02893878
Last Updated: 2019-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
19334 participants
OBSERVATIONAL
2016-09-12
2016-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Vaccinated_Fluarix Tetra Group
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in approximately 10 volunteer practices.
Vaccine safety surveillance
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
Vaccinated_Non GSK Group
Volunteered subjects who received Non-GSK influenza vaccination in approximately 10 volunteer practices.
Vaccine safety surveillance
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
Vaccinated_Unknown Group
Volunteered subjects who received influenza vaccination (GSK or Non-GSK not known) in approximately 10 volunteer practices.
Vaccine safety surveillance
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
Interventions
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Vaccine safety surveillance
Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
ALL
Yes
Sponsors
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University of Surrey
OTHER
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Surrey, , United Kingdom
Countries
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Other Identifiers
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202056
Identifier Type: -
Identifier Source: org_study_id
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