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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2014

At a glance

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

    • 15 May 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 11 Jul 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
    • 16 Feb 2013 New source identified and integrated (European Clinical Trials Database: EudraCT2012-001876-13).
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