Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age
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|ClinicalTrials.gov Identifier: NCT01031303|
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : October 5, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Diphtheria Tetanus Pertussis Poliomyelitis||Biological: DTacP-IPV combined vaccine (TETRAXIM™)||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||January 2011|
|Experimental: Study Group||
Biological: DTacP-IPV combined vaccine (TETRAXIM™)
0.5 mL, Intramuscular
Other Name: TETRAXIM™
- To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination. [ Time Frame: 30 days post-vaccination ]
- To provide information concerning the safety after booster administration of TETRAXIM™. [ Time Frame: 30 days post-vaccination and entire study period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031303
|Bangkok, Thailand, 10330|
|Bangkok, Thailand, 10400|
|Study Director:||Medical Director||sanofi pasteur SA|