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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01042951
Eligibility Criteria:
Inclusion Criteria:
1. Age: 12-23 months for younger children group, 2-5 years for the toddler group and 18-45 years for the adult group.
2. Sex: Either
3. Consent: Written informed consent from study participants and parents in case of children.
4. Compliance to study procedures: e.g. available for follow-up visits and agrees to specimen collection.
5. Apparently healthy: as determined by medical history, physical examination findings, and clinical judgment of the study physician.
Exclusion Criteria:
1. Chronic disease: history or evidence of chronic illness.
2. Gastrointestinal symptoms such as abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours or abdominal pain lasting for more than 2 weeks in the past 6 months
3. Intake of any anti-diarrheal medicine or antimicrobial therapy the past week.
4. Acute disease one week prior to enrollment, with or without fever ≥38ºC .
5. Receiving of cholera vaccine any time in the past, and any other live or killed enteric vaccine in the last 4 weeks.
6. Diarrhea within 6 week period at screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
45 Years
Study:
NCT01042951
Study Brief:
Protocol Section:
NCT01042951