Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319852
Status:
COMPLETED
Last Update Posted:
2012-04-16
First Post:
2006-04-28
Brief Title:
Immunogenicity and Safety of Tetraxim Versus Local DTP IPV
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteurs 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 seroconversionvaccine response rates to Pertussis antigens PT FHA of Sanofi Pasteurs DTaP-IPV combined vaccine versus commercially available Bikens DTaP CJ purified PDT vaccine and Aventis Pasteurs IPV IMOVAX POLIO monovalent vaccines one month after the three-dose primary vaccination
Secondary objectives
1 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seroconversion vaccine response rates to Pertussis antigens PT FHA of Sanofi Pasteurs DTaP-IPV combined vaccine versus historical reference Study E2I03294 - France To assess and describe the immunogenicity of the study vaccines in both groups
2 Safety To assess and describe the safety of the study vaccines after each dose
Primary objective To demonstrate the non-inferiority in terms of seroprotection rates Diphtheria Tetanus Polio types 1 2 and 3 and seroconversionvaccine response rates to Pertussis antigens PT FHA of Sanofi Pasteurs DTaP-IPV combined vaccine versus commercially available Bikens DTaP CJ purified PDT vaccine and Aventis Pasteurs IPV IMOVAX POLIO monovalent vaccines one month after the three-dose primary vaccination
Secondary objectives
1 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seroconversion vaccine response rates to Pertussis antigens PT FHA of Sanofi Pasteurs DTaP-IPV combined vaccine versus historical reference Study E2I03294 - France To assess and describe the immunogenicity of the study vaccines in both groups
2 Safety To assess and describe the safety of the study vaccines after each dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None