A phase III open-label randomised study to evaluate the immunogenicity and safety of the concomitant administration of a new Hexavalent DTaP-IPV-HepB-PRP-T combined vaccine (Hexavalent vaccine) given at 2, 3, and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age

Trial Profile

A phase III open-label randomised study to evaluate the immunogenicity and safety of the concomitant administration of a new Hexavalent DTaP-IPV-HepB-PRP-T combined vaccine (Hexavalent vaccine) given at 2, 3, and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Feb 2017

At a glance

  • Drugs DTaP IPV HepB PRP T vaccine (Primary) ; Meningococcal vaccine group C conjugate (Primary) ; Measles mumps and rubella virus vaccine; Meningococcal vaccine groups A C Y W-135 conjugate; Pneumococcal 13-valent CRM197 vaccine conjugate; Rotavirus W179-9 vaccine
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal group C infections; Pertussis; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics
  • Sponsors sanofi pasteur MSD
  • Most Recent Events

    • 08 Dec 2016 Primary endpoint has been met. (Proportion of subjects with an anti-MenC titre 1:8 dil)
    • 08 Dec 2016 Primary endpoint has been met. (Proportion of subjects with an anti-hepatitis B concentration 10 IU/mL)
    • 08 Dec 2016 Results published in the Vaccine
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