Trial | NCT01707537  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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)
Study Started
Sep 30
2012
Primary Completion
Feb 28
2013
Study Completion
Feb 28
2013
Last Update
Feb 20
2013
Estimate

Biological Euvichol

1.5mL/vial, 1vial at 2-week intervals twice

  • Other names: Oral Cholerae Vaccine

Euvichol Experimental

Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour.

Criteria 

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
No Results Posted