A phase IIIB open, multicountry, randomized, controlled study to demonstrate the non-inferiority of the immune response of GSK Biologicals' meningococcal serogroup A, C, W-135 and Y conjugate vaccine (MenACWY-TT) when given intramuscularly at 2, 4 and 12 months of age or given at 2, 3, 4 and 12 months of age compared to two licensed MenC conjugate vaccine given intramuscularly at 2, 4 and 12 months of age.

Trial Profile

A phase IIIB open, multicountry, randomized, controlled study to demonstrate the non-inferiority of the immune response of GSK Biologicals' meningococcal serogroup A, C, W-135 and Y conjugate vaccine (MenACWY-TT) when given intramuscularly at 2, 4 and 12 months of age or given at 2, 3, 4 and 12 months of age compared to two licensed MenC conjugate vaccine given intramuscularly at 2, 4 and 12 months of age.

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Dec 2016

At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Meningococcal vaccine groups A C Y W-135 conjugate (Primary) ; Meningococcal vaccine group C conjugate; Pneumococcal vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal group A infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 19 Dec 2016 Primary end point (Immunogenicity of 2 MenACWY-TT doses) has been met.
    • 19 Dec 2016 Primary end point (Non-inferiority of 2 MenACWY-TT doses vs 2 MenC-TT doses) has been met.
    • 19 Dec 2016 Primary end point (Non-inferiority of 2 MenACWY-TT doses vs 2 MenC-CRM197 doses) has been met.
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