To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Hea… (NCT01707537) | Clinical Trial Compass
CompletedPhase 1
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
South Korea20 participantsStarted 2012-09
Plain-language summary
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
Who can participate
Age range20 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 im…
What they're measuring
1
Safety(proportion of subjects with adverse events)
Timeframe: From the date of the first orally administered for 4 weeks after the second dose