Phase III, multi-center trial in 795 infants in the Czech Republic, Germany, and Spain. Subjects from the Czech Republic and Germany will be randomized in Groups 1 and 2 to receive in a blind-observer manner, the investigational DTaP IPV HB Hib vaccine or the control vaccine, Infanrix hexa, concomitantly with the administration of Prevenar 13 at 2, 3, and 4 months of age; the subjects from Spain (in Group 3) who had received a first dose of hepatitis B vaccine prior to the study will be allocated to receive in an open-label manner, the investigational DTaP IPV HB Hib vaccine at 2 and 6 months of age, and Pentavac™ vaccine at 4 months of age, concomitantly with Prevenar 13 at 2 and 4 months of age and RotaTeq at 2, 4 and 6 months of age.
Phase of Trial: Phase III
Latest Information Update: 14 May 2018
At a glance
- Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Hib-DTP-hepatitis B vaccine; Pneumococcal 13-valent CRM197 vaccine conjugate; Rotavirus W179-9 vaccine
- Indications Diphtheria; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Rotavirus infections; Tetanus
- Focus Pharmacodynamics; Registrational
- Sponsors sanofi pasteur
- 14 May 2018 Results from U1111-1122-2329 and U1111-1122-2362 studies published in the Pediatric Infectious Disease Journal.
- 28 Feb 2015 Status changed from recruiting to completed as reported by European Clinical Trials Database record.
- 06 Dec 2013 New trial record