NCT02094833

DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 1 Month – 6 Months
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Haemophilus Influenzae Type b Infection
• Poliomyelitis
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-Hep B-PRP~T combined vaccine	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-IPV//PRP~T and Hepatitis B vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-04-01
• Completion: 2016-11-01
• First posted: 2014-03-24
• Last updated: 2017-04-26

Locations

16 sites across 1 country: South Korea