A Phase Iiib, Open, Multi-center Study To Evaluate The Long-term Antibody Persistence At 6, 7, 8, 9 And 10 Years After The Administration Of One Dose Of Meningococcal Conjugate Vaccine Menacwy-tt Versus One Dose Of Meningococcal Polysaccharide Vaccine Mencevax(Registered) Acwy, And To Evaluate The Safety And Immunogenicity Of A Booster Dose Of Menacwy-tt Vaccine Administered 10 Years After Primary Vaccination Of 11-55 Year Old Subjects With Menacwy-tt Or Mencevax (Registered) Acwy.

Trial Profile

A Phase Iiib, Open, Multi-center Study To Evaluate The Long-term Antibody Persistence At 6, 7, 8, 9 And 10 Years After The Administration Of One Dose Of Meningococcal Conjugate Vaccine Menacwy-tt Versus One Dose Of Meningococcal Polysaccharide Vaccine Mencevax(Registered) Acwy, And To Evaluate The Safety And Immunogenicity Of A Booster Dose Of Menacwy-tt Vaccine Administered 10 Years After Primary Vaccination Of 11-55 Year Old Subjects With Menacwy-tt Or Mencevax (Registered) Acwy.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2017

At a glance

  • Drugs Meningococcal vaccine groups A C Y W-135 conjugate (Primary) ; Meningococcal vaccine groups A C Y W-135 polysaccharide
  • Indications Meningococcal infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline; Pfizer
  • Most Recent Events

    • 29 Sep 2017 Planned number of patients changed from 400 to 336.
    • 29 Sep 2017 Planned End Date changed from 1 Jun 2018 to 29 Sep 2018.
    • 29 Sep 2017 Planned primary completion date changed from 1 Nov 2017 to 5 Apr 2018.
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