A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages greater than or equal to 4 Years to less than 18 Years

Trial Profile

A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages greater than or equal to 4 Years to less than 18 Years

Completed
Phase of Trial: Phase III

Latest Information Update: 23 May 2016

At a glance

  • Drugs Influenza A H1N1 H3N2 influenza B Yamagata Victoria vaccine-Novartis (Primary) ; Influenza vaccine (Optaflu) (Primary)
  • Indications Influenza virus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors Novartis Vaccines
  • Most Recent Events

    • 23 May 2016 According to a Seqirus media release, the US FDA has approved FLUCELVAX QUADRIVALENT (Influenza Vaccine) for prevention against two influenza A viruses and two B viruses recommended by WHO and FDA in people aged four years and older.
    • 25 Aug 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 09 Jan 2014 Status changed from recruiting to active, no longer recruiting, as reported by ClinicalTrials.gov.
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