CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19,334 enrolled
Drug / intervention
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/NCT02893878
NCT02893878N/ACompleted
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Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

GlaxoSmithKline·observational·Posted Sep 9, 2016·Updated Feb 11, 2019

In Brief

An observational study evaluating Vaccine safety surveillance for Influenza, Human. Completed, enrolled 19,334 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesUnited Kingdom
CollaboratorsUniversity of Surrey

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 9, 2016
Enrollment StartSep 12, 2016
Primary CompletionNov 24, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.8 years ago

Interventions

Vaccine safety surveillanceother

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.