NCT01031303

Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age

Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given as a Booster Dose at 4 to 6 Years of Life in Children Previously Vaccinated With PENTAXIM™ in the Study E2I34

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP\~T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations. Primary Objective : * To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid \[PT\], Filamentous Haemagglutinin \[FHA\]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age. Secondary Objectives : * To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age. * To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age. * To describe the safety after the booster dose of the study vaccine.

Detailed description

All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age. Participants will receive the study vaccine \[sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)\] at 4 to 6 years of age (at visit 1).

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	DTacP-IPV combined vaccine (TETRAXIM™)	0.5 mL, Intramuscular

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-09-01
• Completion: 2011-01-01
• First posted: 2009-12-14
• Last updated: 2011-10-05

Locations

2 sites across 1 country: Thailand