Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccines
Abstract
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.
Conditions: Influenza, Human.
Primary outcome: Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall; Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group; Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall; Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group; Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall; Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT,…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 1,060 participants or records.
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