A Study to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19)
COVID-19
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Healthy permanent residents aged 18 years and above;
- Subjects agree to sign the informed consent forms voluntarily;
- Subjects are able to comply with the requirements of the clinical trial protocol;
- Armpit temperature <= 37.0 degrees C;
- Female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment.
Exclusion Criteria:
- Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases;
- Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control);
- Subjects with history of SARS virus infection by self-reported;
- Positive in throat swab through RT-PCR;
- Positive in SARS-CoV-2 antibody test;
- Subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine;
- Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history;
- Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >= 90 mmHg; subjects aged >= 60 years with systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases;
- Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
- Subjects receiving anti-TB treatment;
- Subjects receiving other research drugs within 6 months before vaccination;
- Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days);
- Subjects receiving blood products within 3 months before administration;
- Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
- Subjects vaccinated with other vaccine within 7 days before vaccination;
- The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.
Sites / Locations
- Jiangsu Provincial Center for Diseases 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
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
medium dosage on day 0, 14(18~59 years)
high dosage on day 0, 14(18~59 years)
placebo on day 0, 14(18~59years)
medium dosage on day 0, 28(18~59 years)
high dosage on day 0, 28(18~59 years)
placebo on day 0, 28(18~59years)
medium dosage on day 0, 28, 56(18~59 years)
high dosage on day 0, 28, 56(18~59 years)
placebo on day 0, 28, 56(18~59 years)
medium dosage on day 0, 28, 56(>59 years)
high dosage on day 0, 28, 56(>59 years)
placebo on day 0, 28, 56(>59 years)
Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
Two doses of placebo on the schedule of day 0,14
Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28
Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28
Two doses of placebo on the schedule of day 0,28
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Three doses of placebo on the schedule of day 0,28,56
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Three doses of placebo on the schedule of day 0,28,56