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

NCT03278067 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23939

Last updated 2020-01-13

Study results available
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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 interest (AEIs) after Flu vaccination.

Conditions

  • Influenza, Human

Interventions

OTHER

Enhanced vaccine safety surveillance

Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United Kingdom

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278067 on ClinicalTrials.gov