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.
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
- 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.