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A Phase 3, Randomized, Multicenter, Observer-Blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Seqirus Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-Licensed 2015-2016 Quadrivalent Inactivated Comparator Influenza Vaccine (Comparator QIV) in a Pediatric Population 5 Through 17 Years of Age

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A Phase 3, Randomized, Multicenter, Observer-Blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Seqirus Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-Licensed 2015-2016 Quadrivalent Inactivated Comparator Influenza Vaccine (Comparator QIV) in a Pediatric Population 5 Through 17 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 May 2019

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At a glance

  • Drugs Influenza vaccine quadrivalent Seqirus (Primary) ; GSK 2321138A
  • Indications Influenza virus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors bioCSL; Seqirus

    • Most Recent Events

    • 29 Mar 2019 Results comparing the rates of fever observed in children (aged 6 months to <18 years) in the three studies of S-IIV3/S-IIV4 (NCT02212106, NCT02545543 and NCT02914275) prepared using the modified manufacturing process and 3 historical formulation studies: two single-arm studies (FLU-04-05 ; USF-06-29 and one blinded, comparator-controlled study USF-07-36) published in the Vaccine
    • 05 Apr 2017 Results published in the Vaccine
    • 13 Jul 2016 Status changed from active, no longer recruiting to completed.

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