Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02813486
Status:
UNKNOWN
Last Update Posted:
2016-11-06
First Post:
2016-06-20
Brief Title:
Safety and Immunogenicity Study of Tetanus Diphtheria and Acellular Pertussis Tdap Vaccine
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Safety and Immunogenicity Study of Tetanus Diphtheria and Acellular Pertussis Tdap Vaccine
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix vaccine among healthy adults in 19 to 65 years of age
Detailed Description:
To evaluate immunogenicity of GC3111 as tetanus diphtheria and acellular pertussis Tdap vaccine in healthy adults
To evaluate safety solicited adverse events of GC3111 in healthy adults
To evaluate safety solicited adverse events of GC3111 in healthy adults
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