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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT04111432
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteer aged ≥ 8 months;
* Proven legal identity;
* Guardians of the participants 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 EV71 vaccine;
* Prior vaccination with MMR vaccine or vaccine including mumps or measles or mumps or rubella vaccine components;
* Prior vaccination with Encephalitis B vaccine；
* Cannot be vaccinated with both arms at the same time；
* History of hand，foot and mouth disease;
* History of measles or mumps or rubella or encephalitis B；
* Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria,difficulty in breathing, angioneurotic edema, pain, etc;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
* Autoimmune diseases or immunodeficiency/immunosuppression;
* Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis;
* History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy;
* Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
* Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months;
* Receipt of any of the following products:
1. Blood product within 3 months prior to study entry;
2. Any live attenuated vaccine within 14 days prior to study entry;
3. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
4. Any other study drugs within 30 days prior to study entry;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Axillary temperature \> 37.0#;
* 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:
8 Months
Study:
NCT04111432
Study Brief:
Protocol Section:
NCT04111432