Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-03-22 @ 6:51 AM
Study NCT ID:
NCT01867957
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2013-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Anthrax Vaccine, GC1109
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men
Status:
COMPLETED
Status Verified Date:
2013-06
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:
1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.
2. OBJECTIVE
\- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
3. STUDY DESIGN
* single-blinded
* randomized
* placebo controlled
* phase 1 study
2. OBJECTIVE
\- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
3. STUDY DESIGN
* single-blinded
* randomized
* placebo controlled
* phase 1 study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: