A phase II, controlled, single centre, open study to evaluate the safety, reactogenicity and immunogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with a reduced dose of AS03, compared to a second dose of Fluarix(GlaxoSmithKline Biologicals) administered intramuscularly in subjects 18-60 years previously vaccinated in FLU-LD-004 clinical trial.

Trial Profile

A phase II, controlled, single centre, open study to evaluate the safety, reactogenicity and immunogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with a reduced dose of AS03, compared to a second dose of Fluarix(GlaxoSmithKline Biologicals) administered intramuscularly in subjects 18-60 years previously vaccinated in FLU-LD-004 clinical trial.

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Dec 2016

At a glance

  • Drugs GSK 1247446A (Primary) ; AS03A; Influenza virus vaccine
  • Indications Influenza virus infections
  • Focus Adverse reactions
  • Acronyms FLU-LD-010 EXT: 004 Y1
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 02 Oct 2009 Secondary endpoints added as reported by ClinicalTrials.gov.
    • 28 Jan 2008 Status changed from in progress to completed as reported by ClinicalTrials.gov.
    • 27 Oct 2007 New trial record.
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