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.
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
- 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.