A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated (COVID-19)
Covid19
About this trial
This is an interventional prevention trial for Covid19 focused on measuring SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus
Eligibility Criteria
Inclusion Criteria:
- Aged 3 years and above (after enrolled, subjects will be allocated according to age).
- By asking for medical history and physical examination, the health condition judged by the investigators is well.
- Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
- No vaccination history of COVID-19 vaccine before enrollment.
- Be able and willing to complete the whole prescribed study plan.
- With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.
Exclusion Criteria:
- Confirmed cases, suspected cases or asymptomatic infections of SAR-CoV-2 infection (check "China Disease Prevention and Control Information System").
- Has a history of SARS, MERS infection (self-report, on-site inquiry).
- >14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃.
- Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
- With severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
- Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
- Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
- With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
- Received immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
- Received live attenuated vaccinewithin 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
- Received blood products within 3 months before enrolment.
- Received other research drugs within 6 months before enrolment.
- Other circumstances judged by investigators are not suitable for this clinical trial.
Sites / Locations
- Yanjin County Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Experimental
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A1 aged ≥ 71
A2 aged ≥ 71
A3 aged ≥ 71
B1 aged 60-70
B2 aged 60-70
B3 aged 60-70
C1 aged 18-59
C2 aged 18-59
C3 aged 18-59
C4 aged 18-59
D1 aged 9-17
D2 aged 9-17
D3 aged 9-17
D4 aged 9-17
E1 aged 3-8
E2 aged 3-8
E3 aged 3-8
E4 aged 3-8
300 subjects age ≥ 71 (A1)receive 3 doses of vaccine
200 subjects age ≥ 71 (A2)receive 3 doses of vaccine
200 subjects age ≥ 71 (A3) receive 3 doses of vaccine
300 subjects age 60-70 (B1) receive 3 doses of vaccine
200 subjects age 60-70 (B2) receive 3 doses of vaccine
200 subjects age 60-70 (B3) receive 3 doses of vaccine
300 subjects age 18-59 (C1) receive 3 doses of vaccine
200 subjects age 18-59 (C2) receive 3 doses of vaccine
200 subjects age 18-59 (C3) receive 3 doses of vaccine
300 subjects age 18-59 (C4) receive 2 doses of vaccine
300 subjects age 9-17 (D1) receive 3 doses of vaccine
200 subjects age 9-17 (D2) receive 3 doses of vaccine
200 subjects age 9-17 (D3)receive 3 doses of vaccine
300 subjects age 9-17 (D4)receive 2 doses of vaccine
300 subjects age 3-8 (E1) receive 3 doses of vaccine
200 subjects age 3-8 (E2)receive 3 doses of vaccine
200 subjects age 3-8 (E3)receive 3 doses of vaccine
300 subjects age 3-8 (E4)receive 2 doses of vaccine