NCT03688620

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

Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccines

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,060 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
OTHER	Passive enhanced safety surveillance	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).

Timeline

• Start date: 2018-10-05
• Primary completion: 2019-01-04
• Completion: 2019-01-04
• First posted: 2018-09-28
• Last updated: 2024-01-05
• Results posted: 2020-04-08

Locations

9 sites across 3 countries: Belgium, Germany, Spain