CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23,939 enrolled
Drug / intervention
Enhanced vaccine safety surveillanceother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03278067
NCT03278067N/ACompleted

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18

GlaxoSmithKline·observational·Posted Sep 11, 2017·Updated Jan 13, 2020

In Brief

An observational study evaluating Enhanced vaccine safety surveillance for Influenza, Human. Completed, enrolled 23,939 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 11, 2017
Enrollment StartSep 12, 2017
Primary CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.8 years ago

Interventions

Enhanced vaccine safety surveillanceother

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.