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| Name | Class |
|---|---|
| Instituto Universitario IVI | OTHER |
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To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
This clinical trial is open, non-comparative phase 1 clinical studies in healthy men and has been designed to determine the safety and immunogenicity of Euvichol(Oral cholera vaccine)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euvichol | Experimental | Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euvichol | Biological | 1.5mL/vial, 1vial at 2-week intervals twice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety(proportion of subjects with adverse events) | The proportion of all adverse event and serious adverse event which were occured during the entire study period is analyzed and casuality between severity and investigational product is presented. Check the vital signs, physical examination and clinical laboratory tests | From the date of the first orally administered for 4 weeks after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity(vibriocidal antibody assay) | Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline | Baseline(before the administration), 14 days after first dose, 14 days after second dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong J Hee, Ph.D | Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | Chungcheongnam-do | 301-721 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24753695 | Derived | Baik YO, Choi SK, Kim JW, Yang JS, Kim IY, Kim CW, Hong JH. Safety and immunogenicity assessment of an oral cholera vaccine through phase I clinical trial in Korea. J Korean Med Sci. 2014 Apr;29(4):494-501. doi: 10.3346/jkms.2014.29.4.494. Epub 2014 Apr 1. |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| D007239 | Infections |