Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336635
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2006-06-13
Brief Title:
Safety and Immunogenicity of CJ-50300
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Randomized Double Blind Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers Phase I
Status:
COMPLETED
Status Verified Date:
2007-04
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 currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack Thus new manufacturing methods for smallpox vaccine is urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards Recently CJ corporation in Republic of Korea has developed cell-culture derived smallpox vaccine CJ-50300 which was manufactured by infecting MRC-5 cells The aim of this phase 1 clinical trial were to assess safety reactogenicity and immunogenicity of CJ-50300
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