To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men

Phase I Study to Determine the Safety and Immunogenicity of Euvichol(Oral Cholera Prevention Vaccine)in Healthy Adult Men ; Open, Non-comparative Clinical Trial

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)

Inclusion Criteria:

• Adult men over 20years of age
• More than 45kg body weight and ideal body weight within ±20% of the weight
• 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
• Written consent person who determines to participate in a clinical trial

Exclusion Criteria:

• A person who showed hypersensitivity when other preventive vaccination in the past
• A person who have received cholera vaccine in the past
• A person who had a febrile illness or infection disease, or have received antibiotics within 2weeks before the start of the experiment
• 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
• 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
• A person who donate whole blood or component of blood within one months before the start of the experiment if the donors
• A person who received other preventive vaccine within 2months before the start of the experiment
• A person who received blood products of immune globulin preparations within 3months before the start of the experiment
• A person who has immune function disorders or are receiving immunosuppressive treatment
• A person who has chronic illness in progress
• Ongoing drug and alcohol abuse(Not more than 28 units/week for drinking)
• A person who participate in clinical trials treated with the investigational drug within 2months before the start of the experiment
• A person who is difficult to participate in this clinical trials as the discretion of the investigator