Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone Quadrivalent in Children 6 to 35 Months of Age

Trial Profile

Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone Quadrivalent in Children 6 to 35 Months of Age

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2016

At a glance

  • Drugs GSK 2282512A (Primary) ; Influenza virus vaccine
  • Indications Influenza virus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 21 Nov 2016 According to a GSK media release, based on the data from this and other three studies, the US FDA approved supplemental Biologics License Application for FluLaval Quadrivalent (Influenza Vaccine) for use in children of 6 months and older.
    • 11 Apr 2016 Treatment arms changed from 4 to 2.
    • 02 Feb 2016 According to a GlaxoSmithKline media release, the results of this study will be presented at the annual meeting of Pediatric Academic Societies.
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