A phase III open-label randomised study, to evaluate the immunogenicity and safety of the concomitant administration of V419 (PR5I) given at 2, 3 and 4 months of age with two types of meningococcal serogroup C conjugate (MCC) vaccines given at 3 and 4 months of age, and followed by the administration at 12 months of age of a combined Haemophilus influenzae type b-MCC vaccine.

Trial Profile

A phase III open-label randomised study, to evaluate the immunogenicity and safety of the concomitant administration of V419 (PR5I) given at 2, 3 and 4 months of age with two types of meningococcal serogroup C conjugate (MCC) vaccines given at 3 and 4 months of age, and followed by the administration at 12 months of age of a combined Haemophilus influenzae type b-MCC vaccine.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2017

At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hib-meningococcal vaccine group C conjugate; Measles mumps and rubella virus vaccine; Meningococcal vaccine group C conjugate; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Measles; Meningococcal meningitis; Mumps; Pertussis; Pneumococcal infections; Poliomyelitis; Rubella; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors sanofi pasteur MSD
  • Most Recent Events

    • 18 Mar 2014 Status changed from active, no longer recruiting to completed.
    • 23 Jan 2014 Planned End Date changed from 1 Jun 2014 to 1 Jul 2014 according to ClinicalTrials.gov record.
    • 07 Nov 2012 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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