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A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05

Trial Profile

A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Mar 2023

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At a glance

  • Drugs Influenza virus vaccine quadrivalent-Seqirus (Primary) ; Influenza virus vaccine
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Novartis; Novartis Pharma A.G.; Seqirus
  • Most Recent Events

    • 06 Mar 2023 Efficacy endpoint has been removed form the Primary Endpoints. Also the time frames of the new endpoints has been amended.
    • 30 Oct 2020 Results from NCT02255409 and NCT02583256 assessing the safety and immunogenicity of repeated exposure to an MF59-adjuvanted quadrivalent influenza vaccine compared to routine non-adjuvanted quadrivalent influenza vaccine, published in the Vaccine
    • 30 Aug 2019 According to an Seqirus, CSL Media Release, new clinical data from this study were presented at the Options for the Control of Influenza (OPTIONS X) Conference in Singapore.
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