Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06053853
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-09-19
Brief Title:
Post Marketing Surveillance of Diphtheria Antitoxin DAT
Sponsor:
PT Bio Farma
Organization:
PT Bio Farma
Study Overview
Official Title:
Safety Profile of Diphtheria Antitoxin DAT in Indonesia
Status:
COMPLETED
Status Verified Date:
2023-11
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 aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
Detailed Description:
To assess the occurrence of serum sickness after Diphtheria Antitoxin administration
To assess local and systemic reactions within 24 hours to 10 days To assess the occurrence of positive reactions after the sensitivity test skin test To assess the presence of SAE after Diphtheria Antitoxin administration
To assess local and systemic reactions within 24 hours to 10 days To assess the occurrence of positive reactions after the sensitivity test skin test To assess the presence of SAE after Diphtheria Antitoxin administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None