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:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT04612634
Eligibility Criteria:
Inclusion Criteria:
1. subjects aged from 18 to 24 months old at the date of recruitment;
2. with informed consent signed by parent(s) or guardians;
3. parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
4. subjects have not been vaccinated with any type of Hepatitis A vaccines;
5. subjects have no Hepatitis A disease and contraindication of vaccination;
6. subjects did not receive any vaccines within 14 days;
7. before joining this trial, subjects must be qualified and passed their medical history and clinical examinations, and axillary's temperature must be ≤37℃.
Exclusion Criteria:
1. Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history;
2. Allergic to any ingredient of vaccine or with allergy history to any vaccine;
3. Patients with immunodeficiency, in process of cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or in close contact with any family members who has congenital immune diseases;
4. Receive non-specific immunoglobulin within 1 month before recruitment;
5. Subjects with acute febrile diseases with body temperature \> 37.0 ℃ or infectious diseases;
6. Subjects with a history of thrombocytopenia or other coagulation disorders that may be contraindicated for hypodermic injection;
7. With known or suspected concurrent diseases include respiratory disease, acute infection or active chronic disease;
8. With severe cardiovascular diseases (Pulmonary heart disease, Pulmonary edema, hypertension cannot be controlled to normal range by drugs), liver and kidney diseases and diabetic complications;
9. Various infectious, suppurative or allergic dermatitis;
10. Other circumstances judged by investigators that are not suitable for this clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
24 Months
Study:
NCT04612634
Study Brief:
Protocol Section:
NCT04612634