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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT05732766
Eligibility Criteria:
Inclusion Criteria:
1. Participants /Legally acceptable representatives who have the ability to provide written informed consent.
2. Participants of either gender of age \> 1 year.
3. Expressed interest and availability to fulfill the study requirements.
1. Willing to receive two doses of the vaccine at the specific study site.
2. Willing to be contacted on the phone to assess adverse events and for study reminders.
4. Agrees not to participate in another clinical study at any time during the study period.
Exclusion Criteria:
1. Any history of anaphylaxis in relation to vaccination.
2. Participants with Immune function disorders including immunodeficiency diseases, or taking immunosuppressive/cytotoxic agents.
3. An individual is thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
4. Participants with 38℃ or higher body temperature measured within 24 hours or at the time of investigational product dosing.
5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours before study initiation
6. Diarrhea or administration of anti-diarrheal drugs or antibiotics to treat diarrhea within 1 week before study initiation.
7. Other vaccination within 4 weeks before study initiation.
8. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months before study initiation.
9. Participation in another clinical trial.
10. History of cholera vaccinations or history of cholera diarrhea.
11. Pregnancy, lactation or willingness/intention to become pregnant during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
99 Years
Study:
NCT05732766
Study Brief:
Protocol Section:
NCT05732766