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A Phase III, open, randomized, controlled, multicenter study to assess the immunogenicity and reactogenicity of GSK Biologicals' meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT) administered alone as compared to MenACWY-TT co-administered with a licensed viral vaccine or co-administered with a licensed viral vaccine and GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) (Boostrix) in female adolescents and young adults at 9-25 years of age

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Trial Profile

A Phase III, open, randomized, controlled, multicenter study to assess the immunogenicity and reactogenicity of GSK Biologicals' meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT) administered alone as compared to MenACWY-TT co-administered with a licensed viral vaccine or co-administered with a licensed viral vaccine and GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) (Boostrix) in female adolescents and young adults at 9-25 years of age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs DTaP vaccine (Primary) ; Human papillomavirus vaccine recombinant bivalent Japan Vaccine/MedImmune (Primary) ; Meningococcal vaccine groups A C Y W-135 conjugate (Primary)
  • Indications Cervical cancer; Diphtheria; Human papillomavirus infections; Meningococcal infections; Pertussis; Tetanus
  • Focus Registrational; Therapeutic Use
  • Acronyms MenACWY-TT-054
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

    • Most Recent Events

    • 29 May 2018 According to EudraCT record this trial was also planned in Brazil.
    • 19 May 2018 Primary endpoint (Non-inferiority of MenACWY-TT coadministered with AS04-HPV16/18 compared to MenACWY-TT ) has been met, as per the results published in Vaccine.
    • 19 May 2018 Primary endpoint (Non-inferiority of AS04-HPV16/18 coadministered with MenACWY-TT and Tdap compared to AS04-HPV16/18 co-administered with Tdap) has been met, as per the results published in Vaccine.

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