Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04238975
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2020-01-08
Brief Title:
A Study to Evaluate the Safety and EfficacyImmunogenicity of GC3111 in Healthy Adults
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Randomized Double-blind Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
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 and efficacy immunogenicity of a single dose of GC3111 versus Boostrix vaccine among healthy adults in 19-64 years of age
Detailed Description:
To evaluate immunogenicity of GC3111 as tetanus diphtheria and acellular pertussis Tdap vaccine in healthy adults
To evaluate safety of GC3111 in healthy adults
To evaluate safety of GC3111 in healthy adults
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