Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT03724357
Eligibility Criteria:
Inclusion Criteria:
* 1\. Age 18 years to 64 years at the time of enrollment
* 2\. Good general health as determined by a screening evaluation within 28 days before blood donation or vaccination
* 3\. Provides written informed consent prior to initiation of any study procedures
Exclusion Criteria:
* 1\. History of any of the following medical conditions:
* Diabetes
* Cancer in past 5 years (except for basal cell carcinoma of the skin and cervical carcinoma in situ)
* Heart disease (e.g., hospitalization for a heart attack, coronary artery bypass graft, arrhythmia, or syncope, within past 5 years. Current symptoms of heart disease, such as dyspnea, angina, or orthopnea)
* Recurrent infections (e.g., more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
* Current drug or alcohol abuse
* Active ulcer disease or ongoing intestinal condition
* Treatment for anemia in last 6 months
* Treatment with anti-malarial drugs within ten days prior to study vaccination
* Treatment with antibiotics within 14 days prior to study vaccination
* Immunodeficiency or immunosuppression from illness or treatment
* 2\. Close contact within 7 days following study vaccination with a person who has an immunodeficiency or immunosuppression from illness or treatment
* 3\. History of cholera infection or cholera vaccination
* 4\. Any of the following complete blood count (CBC) abnormalities during screening:
* white blood cells (WBC) \<0.81 x lower limit of normal (LLN) or \> 1.09 x upper limit of normal (ULN)
* Hemoglobin \<0.91 x LLN or \>1.18 x ULN (women) or \<0.92 x LLN or \>1.18 x ULN (men)
* Platelet count \<0.8 x LLN or \> 1.2 x ULN
* 5\. Any of the following laboratory abnormalities during screening:
* serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \>1.5 times normal
* Positive serology for HIV antibody
* 6\. Poor peripheral venous access for blood donation
* 7\. Other condition that the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or interfere with the scientific integrity of study
* 8\. Positive urine pregnancy test (HCG) on the day of vaccination
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03724357
Study Brief:
Protocol Section:
NCT03724357