At a glance
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Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccines
In Brief
A Phase 4 clinical trial evaluating Passive enhanced safety surveillance for Influenza, Human. Completed, enrolled 1,060 participants across 9 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged \<9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).