Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2009-02-28
2009-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Low-dose GC1109
Low-dose GC1109
50ug/dose
Low-dose Placebo
Low-dose Placebo
0.9% Saline 0.5 mL
High-dose GC1109
High-dose GC1109
100ug/dose
High-dose Placebo
High-dose Placebo
0.9% Saline 1.0 mL
Interventions
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Low-dose GC1109
50ug/dose
High-dose GC1109
100ug/dose
Low-dose Placebo
0.9% Saline 0.5 mL
High-dose Placebo
0.9% Saline 1.0 mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18.5kg/m2 ≤BMI \< 30kg/m2 at the time of screening visit
3. Subjects without congenital or chronic disorder
Exclusion Criteria
18 Years
45 Years
MALE
Yes
Sponsors
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Green Cross Corporation
INDUSTRY
LSK Global Pharma Services Co. Ltd.
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
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Myoung-don Oh
Professor, Division of Infectious Diseases, Department of Internal Medicine
Principal Investigators
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Myoung-don Oh, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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GC1109_P1_v1.2
Identifier Type: -
Identifier Source: org_study_id
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