Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13), at 3, 5, 11 to 12 Months of Age in Healthy Infants. Phase III, randomized, blind-observer, active-controlled, multi-center trial in 554 infants in Finland and Sweden
Phase of Trial: Phase III
Latest Information Update: 06 Oct 2016
At a glance
- Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Pneumococcal 13-valent CRM197 vaccine conjugate
- Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
- Focus Pharmacodynamics; Registrational
- Sponsors sanofi pasteur
- 06 Oct 2016 Results published in the Pediatric Infectious Disease Journal.
- 26 Apr 2014 Status changed from recruiting to completed as reported by European Clinical Trials Database record.
- 16 Aug 2012 New trial record