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A phase IIa, observer-blind, multi-country, multicentre, randomised study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals' quadrivalent influenza vaccine (QIV) adjuvanted with various doses of the AS03 (GSK2584786A), administered in children aged 6 to 35 months, and compared to non-adjuvanted QIV and Fluarix.

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Trial Profile

A phase IIa, observer-blind, multi-country, multicentre, randomised study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals' quadrivalent influenza vaccine (QIV) adjuvanted with various doses of the AS03 (GSK2584786A), administered in children aged 6 to 35 months, and compared to non-adjuvanted QIV and Fluarix.

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 23 Sep 2023

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At a glance

  • Drugs GSK 2321138A (Primary) ; Influenza virus vaccine (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 23 Apr 2012 Actual patient number 4 added as reported by ClinicalTrials.gov.
    • 23 Apr 2012 Actual end date changed from Oct 2011 to Mar 2011 as reported by ClinicalTrials.gov.
    • 17 Apr 2012 Planned number of patients changed from 4 to 1120 as reported by European Clinical Trials Database.

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