Hepatitis B Clinical Trial
Official title:
Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP~T Combined Vaccine at 2, 4, and 6 Months of Age Versus Sanofi Pasteur's DTaP IPV//PRP~T Combined Vaccine at 2, 4, and 6 Months of Age + Hep B Vaccine at 1 and 6 Months of Age, in South Korean Infants Primed With Hep B at Birth
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep
B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6
months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™)
given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of
age in South Korean infants that received a birth dose of Hep B and born to mothers
documented to be serum anti-HBs Ag negative.
Primary Objective
- To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus,
poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens
(pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B,
one month after the third dose of combined vaccines.
Secondary Objectives:
- To further study the immunogenicity of the two vaccination schemes, before the first
dose and one month after the last dose of vaccines.
- To study the safety after each and any dose of vaccines administered in the two
vaccination schemes
Study participants who received a first dose of recombinant Hep B vaccine at birth will receive either DTaP-IPV-Hep B-PRP~T combined vaccine at 2, 4, and 6 months of age + 3 doses of Hep B vaccine or Hep B vaccine (Euvax B®) at 1 and 6 months of age and DTaP IPV//PRP~T combined vaccine (Pentaxim™) at 2, 4, and 6 months of age, according to the official vaccination schedule for Hep B, DTaP, poliovirus, and Hib vaccinations in South Korea. ;
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