A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age.

Trial Profile

A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age.

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2017

At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hib-DTaP-poliovirus vaccine (Primary) ; Meningococcal vaccine group C conjugate; Pneumococcal 13-valent CRM197 vaccine conjugate; Rotavirus W179-9 vaccine
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal group C infections; Pertussis; Pneumococcal infections; Poliomyelitis; Rotavirus infections; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors sanofi pasteur MSD
  • Most Recent Events

    • 07 Jun 2014 Trial status changed from active, no longer recruiting to completed as reported by European Clinical Trials Database.
    • 15 Oct 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
    • 26 Apr 2013 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health: NCT01839188).
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