KCT0000540
Completed
N/A
Phase I study to Determine the Safety and Immunogenicity of Euvichol(Oral Cholera Prevention Vaccine)in Healthy Adult Men ; Open, Non-comparative clinical trial
Eubiologics0 sites20 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Eubiologics
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Adult men over 20years of age
- •2\) More than 45kg body weight and ideal body weight within ±20% of the weight
- •3\)Screening was conducted within 14 days of investigational drug administration (Vital Sign \& Physical Examination, hematology and blood coagulation tests, blood chemistry tests, urinalysis, 12\-lead ECG, etc.), the results at the discretion of the investigator deemed suitable for participation in clinical trials
- •4\) Written consent person who determines to participate in a clinical trial
Exclusion Criteria
- •1\) A person who showed hypersensitivity when other preventive vaccination in the past
- •2\) A person who have received cholera vaccine in the past
- •3\) A person who had a febrile illness or infection disease, or have received antibiotics within 2weeks before the start of the experiment
- •4\) A person who had gastrointestinal symptoms such as diarrhea, abdominal pain, or have been received prescription drug within one week before the start of the experiment
- •5\) A person who was lasted for more than two weeks of symptoms such as diarrhea, abdominal pain within 6months before the start of the experiment
- •6\) A person who donate whole blood or component of blood within one months before the start of the experiment if the donors
- •7\) A person who received other preventive vaccine within 2months before the start of the experiment
- •8\) A person who received blood products of immune globulin preparatios within 3months before the start of the experiment
- •9\) A person who has immune function disorders or are receiving immunosuppressive treatment
- •10\) A person who has chronic illness in progress
Outcomes
Primary Outcomes
Not specified
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