Status:
UNKNOWN
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)
Lead Sponsor:
Beijing Minhai Biotechnology Co., Ltd
Collaborating Sponsors:
Shenzhen Kangtai Biological Products Co., LTD
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04756323
Start Date
October 27 2020
End Date
February 28 2022
Last Update
February 17 2021
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210000