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Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

NCT02893878 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19334

Last updated 2019-02-11

Study results available
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Summary

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.

Conditions

  • Influenza, Human

Interventions

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-12
Primary Completion
2016-11-24
Completion
2016-11-24

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 NCT02893878 on ClinicalTrials.gov