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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT05165966
Eligibility Criteria:
Inclusion Criteria:
* Healthy participants aged 18 years and above;
* Proven legal identity;
* The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
* Have received two doses of inactivated COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd and that is currently 5-9 months after the second dose.
Exclusion Criteria:
* History of SARS-CoV-2 infection(laboratory confirmed);
* Have received three and more doses of inactivated COVID-19 vaccine;
* Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
* Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
* Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
* 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) in the past 6 months;
* History of alcohol or drug abuse;
* Receipt of blood products within in the past 3 months;
* Receipt of other investigational drugs in the past 30 days;
* Receipt of attenuated live vaccines in the past 14 days;
* Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
* Axillary temperature \>37.0°C;
* Participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period;
* 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:
18 Years
Study:
NCT05165966
Study Brief:
Protocol Section:
NCT05165966