Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV
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|ClinicalTrials.gov Identifier: NCT00319852|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 16, 2012
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea.
Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination.
- Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups.
- Safety: To assess and describe the safety of the study vaccines after each dose.
|Condition or disease||Intervention/treatment||Phase|
|Pertussis Diphtheria Poliomyelitis Tetanus||Biological: DTaP-IPV combined vaccine Biological: DTaP vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||442 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2006|
|Primary Completion Date :||April 2008|
|Study Completion Date :||July 2008|
Biological: DTaP-IPV combined vaccine
0.5 mL, IM
Other Name: TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis
|Active Comparator: 2||
Biological: DTaP vaccine
0.5 mL, IM
Other Name: DTaP vaccine (CJ purified PDT vaccine ™)
- To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines. [ Time Frame: 1 month post-vaccination ]
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): NCT00319852
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Study Director:||Clinical Trials||Sanofi Pasteur, a Sanofi Company|