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A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age

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Trial Profile

A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2023

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At a glance

  • Drugs Influenza virus vaccine quadrivalent-Seqirus (Primary) ; MF 59
  • Indications Influenza A virus H1N1 subtype; Influenza A virus H3N2 subtype; Influenza B virus infections; Influenza virus infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis; Novartis Vaccines; Seqirus

    • Most Recent Events

    • 24 May 2020 Russia was the planned location according to European Clinical Trials Database
    • 12 May 2020 Results published in the Pediatric Infectious Disease Journal
    • 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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