Tetanus Clinical Trial
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
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.
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).
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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