Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304265
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2006-03-16
Brief Title:
Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Reactogenicity of Acellular Pertussis Vaccine Booster in Adolescents Who Have Received 5 Prior Doses of BIKEN Acellular Pertussis Vaccine in Combination With Diphtheria and Tetanus Toxoids TRIPEDIA or Who Have Received Primary Vaccination With 3 Doses of Whole-Cell Pertussis Vaccine Plus at Least 1 Pertussis Booster Vaccination
Status:
COMPLETED
Status Verified Date:
2016-04
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:
Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine
To describe and characterize adverse events occurring after vaccination with REPEVAX Tdap-IPV combination diphtheria tetanus and acellular pertussis with inactivated poliomyelitis vaccine or COVAXIS Tdap combination diphtheria tetanus and acellular pertussis vaccine among two groups Group 1 - adolescents 10-14 years of age who participated in study 371-0301 and thus received a 5th dose of TRIPEDIA vaccine and Group 2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life
To describe and characterize adverse events occurring after vaccination with REPEVAX Tdap-IPV combination diphtheria tetanus and acellular pertussis with inactivated poliomyelitis vaccine or COVAXIS Tdap combination diphtheria tetanus and acellular pertussis vaccine among two groups Group 1 - adolescents 10-14 years of age who participated in study 371-0301 and thus received a 5th dose of TRIPEDIA vaccine and Group 2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life
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