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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT05585567
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 -59 years old at time of consent, male or female;
* Normal body temperature;
* Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
* Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
* Be able and willing to complete the study during the entire study and follow-up period;
* Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.
Exclusion Criteria:
* Serious chronic diseases or uncontrolled diseases;
* Uncontrolled neurological disorders, epilepsy;
* Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
* Patients with congenital or acquired immunodeficiency;
* History of severe allergy or be allergic to any components of the test vaccines;
* History of hereditary hemorrhagic tendency or coagulation dysfunction;
* Patients with malignant tumors and other patients have a life expectancy less than 1 year;
* Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
* History of previous COVID-19 infection;
* Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
* Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
* Those considered by the investigator as inappropriate to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT05585567
Study Brief:
Protocol Section:
NCT05585567