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 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
NCT ID:
NCT02189603
Eligibility Criteria:
Inclusion Criteria:
* Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
* Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
* Subjects will reside in the study region in the next 7 months.
* Free of history of hepatitis E.
* Can comply with the request of study.
* Axillary temperature is below 37 degree centigrade.
Exclusion Criteria:
For dose 1:
* receiving other vaccine or immunoglobulin within two weeks;
* Having serious allergic history to vaccine and medicine
* Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
* Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
* Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, HIV or other factors;
* Congenital malformation, eccyliosis or severe chronic disease;
* Fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
* joining other clinical study undergoing;
* women pregnant or in lactation.
For dose 2 or 3:
* Severe allergy for dose 1 or 2;
* Severe adverse reaction associated with last vaccination;
* New occurrence of symptoms meet dose 1 exclusion criteria after the first dose.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02189603
Study Brief:
Protocol Section:
NCT02189603