Official Title
Evaluation of the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above: a Randomized, Double-blind, Placebo Parallel-controlled Phase II Clinical Trial
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 healthy adults ⩾18 years.

Unknown status
COVID-19

Biological: medium dosage inactivated SARS-CoV-2 vaccine

medium dosage

Biological: high dosage inactivated SARS-CoV-2 vaccine

high dosage

Biological: Placebo

placebo

Eligibility Criteria

Inclusion Criteria:

1. Healthy permanent residents aged 18 years and above;

2. Subjects agree to sign the informed consent forms voluntarily;

3. Subjects are able to comply with the requirements of the clinical trial protocol;

4. Armpit temperature <= 37.0 degrees C;

5. 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:

1. 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;

2. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to
Information System of China Disease Prevention and Control);

3. Subjects with history of SARS virus infection by self-reported;

4. Positive in throat swab through RT-PCR;

5. Positive in SARS-CoV-2 antibody test;

6. 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;

7. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or
family history;

8. Subjects with congenital malformations or developmental disorders, genetic defects,
severe malnutrition, etc.;

9. 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;

10. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection,
lymphoma, leukemia or other autoimmune diseases;

11. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency,
coagulation disease);

12. Subjects receiving anti-TB treatment;

13. Subjects receiving other research drugs within 6 months before vaccination;

14. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently
oral or infusion for more than 14 days);

15. Subjects receiving blood products within 3 months before administration;

16. Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;

17. Subjects vaccinated with other vaccine within 7 days before vaccination;

18. The researchers shall judge the other conditions which might be not in compliance with
the requirements of this clinical trial.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China

Beijing Minhai Biotechnology Co., Ltd
NCT Number
MeSH Terms
COVID-19
Vaccines