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

NCT01031303 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2011-10-05

No results posted yet for this study

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.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis

Interventions

BIOLOGICAL

DTacP-IPV combined vaccine (TETRAXIM™)

0.5 mL, Intramuscular

Sponsors & Collaborators

Principal Investigators

  • Medical Director · sanofi pasteur SA

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-09-30
Completion
2011-01-31

Countries

  • Thailand

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01031303 on ClinicalTrials.gov