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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT05526820
Eligibility Criteria:
Inclusion Criteria:
* Healthy child aged 1 year old (12-15 months old);
* Proven legal identity;
* The subjects'guardians should be capable of understanding the informed consent form, and such form should be signed prior to enrolment.
Exclusion Criteria:
* History of vaccination of varicella vaccine or hepatitis A vaccine.
* Previous history of varicella infection or hepatitis A infection;
* History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
* Thyroid disease or history of thyroidectomy, asplenia,functional asplenia,asplenia or splenectomy resulting from any condition;
* Suffering from serious chronic diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, etc;
* Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before enrollment;
* Receipt of blood products within the past 3 months;
* Receipt of other investigational vaccines or drugs within 28 days prior to receiving the investigational vaccine;
* Receipt of attenuated live vaccines in the past 28 days;
* Receipt of inactivated or subunit vaccines in the past 7 days;
* Onset of various acute or chronic diseases within 7 days prior to the study;
* Armpit temperature in subjects with fever prior to vaccination with the investigational vaccine. 37.4 ℃;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
15 Months
Study:
NCT05526820
Study Brief:
Protocol Section:
NCT05526820