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A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)

Trial Profile

A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2023

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At a glance

  • Drugs Influenza virus vaccine (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline; GSK
  • Most Recent Events

    • 19 Feb 2018 Results of pooled post hoc analysis of NCT00764790, NCT00980005 and NCT00383123 trials assessing the relation of fever and antipyretic use to each other and to vaccine immunogenicity published in the Pediatric Infectious Disease Journal
    • 27 Apr 2010 Results published in Pediatric Infectious Disease Journal.
    • 14 Sep 2008 Actual patient number (3327) added as reported by ClinicalTrials.gov.
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