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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT05012800
Eligibility Criteria:
Inclusion Criteria:
* A COVID-19 vaccine is planned.
* Older adults subjects aged 60-80 years or young adults subjects aged 18-59 years.
* Able and willing to follow the requirements of the clinical trial protocol and complete the study follow-up for 12 months.
* HBsAg, anti-HCV, HIV and TPHA were negative.
* Body temperature ≤37.0℃.
Exclusion Criteria:
* People who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
* Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
* Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
* Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc.
* Patients with congenital or acquired angioedema / neuroedema.
* Patients with lymphoma, leukemia and other systemic malignancies.
* Patients with convulsions, epilepsy, encephalopathy, psychiatric disorders and other progressive neurological disorders, or a family history of them.
* Patients with acute attack of chronic diseases.
* During vaccination, immunomodulators, systemic cytotoxic drugs, immune checkpoint inhibitors (PD-1 / PDL-1 / CTLA-4, etc.) and cell therapy, including NK cells, cytokine induced killer cells, Dendritic cells, CTL and Stem cells infusion are required.
* Other conditions determined by the researcher.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05012800
Study Brief:
Protocol Section:
NCT05012800