Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Phase 2 Completed 624 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupOpen-labelPrevention

Summary

Primary Objective: * To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP\~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series. Secondary Objectives: * To describe in each group the immunogenicity parameters one month after the three-dose primary series. * To describe safety profile after each vaccination in both groups.

Timeline

Start: 2004-10
Primary completion: 2005-11
Completion: 2007-03

Outcome

Met primary endpoint

paper The DTaP-IPV-Hep B-PRP-T vaccine was demonstrated as noninferior to the Pentaxim and Hep B monovalent vaccines with seroprotection/seroconversion rates PMID 21372751 ↗

Publications

Results Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. Pediatr Infect Dis J. 2011 Jun;30(6):e88-96. doi: 10.1097/INF.0b013e318212eb80.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DTaP-IPV-HB-PRP~T	Vaccine	0.5 ml	Intramuscular
Comparator	DTaP-IPV//PRP~T combined vaccine	Unknown	0.5 ml	Intramuscular
Comparator	Recombinant hep B vaccine	Vaccine	0.5 ml	Intramuscular