To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Me
- Conditions
- Not Applicable
- Registration Number
- KCT0000540
- Lead Sponsor
- Eubiologics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 20
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
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
11) Ongoing drug and alcohol abuse(Not more than 28 units/week for drinking)
12) A person who participate in clinical trials treated with the investigational drug within 2months before the start of the experiment
13) A person who is difficult to participate in this clinical trials as the discretion of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety, Tolerability
- Secondary Outcome Measures
Name Time Method Immunogenicity(Evaluation of antibody seroconversion)