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.
Phase of Trial: Phase III
Latest Information Update: 27 Feb 2019
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 MCM Vaccine; sanofi pasteur MSD
- 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).