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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT04640402
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years and above.
* Able to understand the content of informed consent and willing to sign the informed consent.
* Able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months).
* Axillary temperature ≤37.0℃.
* General good health as established by medical history and physical examination.
Exclusion Criteria:
First dose exclusion criteria:
* Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-2.
* A Known History of HIV infection
* Family history of seizure, epilepsy, brain or mental disease.
* Participant that has an allergic history to any ingredient of vaccines.
* Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months.
* Any acute fever disease or infections.
* Have a medical history of SARS.
* Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled.
* Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled.
* Hereditary angioneurotic edema or acquired angioneurotic edema.
* Urticaria in last one year.
* Asplenia or functional asplenia.
* Platelet disorder or other bleeding disorder may cause injection contraindication.
* Faint at the sight of blood or needles.
* Prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months.
* Prior administration of blood products in last 4 months.
* Prior administration of other research medicines in last 1 month.
* Prior administration of attenuated vaccine in last 1 month.
* Prior administration of subunit vaccine or inactivated vaccine in last 14 days.
* Being treated for tuberculosis.
* Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives.
Exclusion criteria for subsequent doses:
* Patients with severe allergic reactions after the previous dose of vaccination;
* Patients with serious adverse events causally related to the previous dose of vaccination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04640402
Study Brief:
Protocol Section:
NCT04640402