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Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

Influenza, Human Clinical Trial

Official title:
Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccines

Clinical Trial Summary

The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain). This study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in Europe.

Clinical Trial Description

The key objective of the EMA enhanced safety surveillance is to rapidly detect a significant increase in the frequency and/or severity of expected reactions (local, systemic or allergic reactions) that may indicate a potential risk. The study is a passive enhanced safety surveillance aiming to collect prospectively AEIs and/or other AEs experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine, using customized Adverse Drug Reaction cards. Data will be collected via the healthcare provide (HCP) or study medical staff who administer the seasonal influenza vaccination or who provide the inform consent form and the ADR cards. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03688620
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 4
Start date October 5, 2018
Completion date January 4, 2019
View Details
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