Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258882
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2005-11-24
Brief Title:
Descriptive Post-marketing Passive Surveillance Safety Study of ADACEL Vaccine
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Post-licensure Safety Surveillance Study of Routine Use of Tetanus Toxoid Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Adacel
Status:
COMPLETED
Status Verified Date:
2018-06
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:
To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events AEs not detected during pre-licensure studies
Detailed Description:
Surveillance using a healthcare organization with large comprehensive medical encounter databases will be used in this study to identify any risks or uncommon events associated with use of the recently licensed Adacel vaccine that may occur in routine clinical usage in a large population
No investigational vaccines will be administered in this study Participants will be included in the study on the basis of their having received Adacel vaccine as part of routine care
No investigational vaccines will be administered in this study Participants will be included in the study on the basis of their having received Adacel vaccine as part of routine care
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