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A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES

Trial Profile

A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2019

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At a glance

  • Drugs Meningococcal vaccine groups A C Y W-135 conjugate (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Meningococcal infections; Pneumococcal infections
  • Focus Pharmacodynamics; Registrational
  • Acronyms MENACWY-TT-104
  • Sponsors GlaxoSmithKline; Pfizer
  • Most Recent Events

    • 01 Mar 2018 Primary endpoint (Immunogenicity with respect to components of the study vaccines in terms of antibody concentration) has been met as per the results published in the Vaccine
    • 01 Mar 2018 Primary endpoint (Immunogenicity with respect to components of the study vaccines in terms of rSBA titres) has been met as per the results published in the Vaccine
    • 01 Mar 2018 Results assessing short term immunogenicity and safety data upto 9 months post first vaccination published in the Vaccine
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