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A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months

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A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2022

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At a glance

  • Drugs Influenza vaccine (Optaflu) (Primary) ; Influenza virus vaccine
  • Indications Influenza virus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors Seqirus

    • Most Recent Events

    • 15 Oct 2021 According to a Seqirus Media Release, the U.S. Food and Drug Administration (FDA) has approved FLUCELVAX QUADRIVALENT (Influenza Vaccine) for an expanded age indication for children as young as six months old, based on data from this trial.
    • 03 May 2021 According to a Seqirus Media Release, data from this study will support supplemental Biologics License Application (sBLA) filing which us currently under review with the U.S. Food and Drug Administration (FDA), for use of QIVc for immunization against seasonal influenza in the U.S. for persons six months and above.
    • 03 May 2021 According to a Seqirus Media Release, Brandon J. Essink is the principal investigator for this study.

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