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

Phase 4

Completed

• Conditions: Diphtheria; Tetanus; Pertussis; Poliomyelitis
• Interventions: Biological: DTacP-IPV combined vaccine (TETRAXIM™)

• Registration Number: NCT01031303
• Lead Sponsor: Sanofi

Brief 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).

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-14
• Primary Completion: 2010-09
• Study Completion: 2011-01
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	DTacP-IPV combined vaccine (TETRAXIM™)	-

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.	30 days post-vaccination

Secondary Outcome Measures

Name	Time	Method
To provide information concerning the safety after booster administration of TETRAXIM™.	30 days post-vaccination and entire study period