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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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Daejeon, South Korea
Gyeonggi-do, South Korea
Gyeonggi-do, South Korea
Gyeongsangnam Do, South Korea
Gyeongsangnam Do, South Korea
Jeollabuk Do, South Korea
Jeonbuk, South Korea
Kangwon Do, South Korea
Kyunggi Do, South Korea
Seoul, South Korea
Start Date
March 1, 2014
Primary Completion Date
April 1, 2016
Completion Date
November 1, 2016
Last Updated
April 26, 2017
310
ACTUAL participants
DTaP-IPV-Hep B-PRP~T combined vaccine
BIOLOGICAL
DTaP-IPV//PRP~T and Hepatitis B vaccine
BIOLOGICAL
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
NCT07203755
NCT07112144
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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