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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT02965404
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteer between 1 - 49 years old;
* Proven legal identity;
* Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study;
Exclusion Criteria:
* Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
* Axillaty temperature \> 37.0 °C;
* Breast feeding, pregnant, or expected to conceive during the period of this trial;
* History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
* History of epilepsy, seizures or convulsions, or a family history of mental illness;
* Autoimmune disease or immunodeficiency;
* Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Receipt of any of the following products:
1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
2. Any live attenuated vaccine within 1 month prior to study entry;
3. Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry;
* Any significant abnormity of heart, lung, skin, or pharynx;
* Any of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity:
1. Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
2. Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine;
3. Urine routine tests: urine protein, urine glucose, urine erythrocyte
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
49 Years
Study:
NCT02965404
Study Brief:
Protocol Section:
NCT02965404