Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467519
Status:
COMPLETED
Last Update Posted:
2014-02-07
First Post:
2007-04-27
Brief Title:
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Currently there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 yearsThis study is aimed at providing evidence of sero-protection booster response and safety of this formulation as a 5th dose
Primary Objective
- To compare the immune responses of Tetanus toxoid reduced diphtheria toxoid and acellular pertussis Tdap Vaccine to Diphtheria tetanus and acellular pertussis DTaP vaccine all antigens when each is administered as a 5th dose and given concurrently to children aged 4 to 6 years
SecondaryObservational Objectives
To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine for pertussis antigens when each is administered as a 5th dose and given concurrently to children aged 4 to 6 years
To present the long-term immunogenicity at 1- 3- and 5-years post-vaccination after each long-term follow-up
To describe the safety profile following vaccine administration
Primary Objective
- To compare the immune responses of Tetanus toxoid reduced diphtheria toxoid and acellular pertussis Tdap Vaccine to Diphtheria tetanus and acellular pertussis DTaP vaccine all antigens when each is administered as a 5th dose and given concurrently to children aged 4 to 6 years
SecondaryObservational Objectives
To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine for pertussis antigens when each is administered as a 5th dose and given concurrently to children aged 4 to 6 years
To present the long-term immunogenicity at 1- 3- and 5-years post-vaccination after each long-term follow-up
To describe the safety profile following vaccine administration
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