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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-02-28

Brief Summary

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

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Detailed Description

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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)

Conditions

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Prevention Harmful Effects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Euvichol

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

Group Type EXPERIMENTAL

Euvichol

Intervention Type BIOLOGICAL

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

Interventions

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Euvichol

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Oral Cholerae Vaccine

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes