drugset / Trial / NCT00654901

Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

NCT00654901

Phase 3 Completed 881 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP\~T or Infanrix hexa™. * To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP\~T in a subset of subjects. Safety \- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP\~T.

Timeline

Start
2008-03
Primary completion
2009-05
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Infanrix hexa Vaccine 0.5 ml Intramuscular
Subject Prevnar 13 Vaccine 0.5 ml Intramuscular