The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19

Inclusion Criteria:

1. Adults aged 18 years and above (including boundary values), both female and male.

2. Legal identification of the participants shall be provided.

3. Participants shall understand the content in the Informed Consent Form (ICF) and the
vaccine for administration, sign the ICF voluntarily and are capable of using
thermometers and rulers, and filling in diary cards and contact cards as per the
requirements.

4. Subject shall be able to communicate well with investigators, understand and comply
with the requirements of this study.

5. Participants with oral temperature ≤ 37.9 ℃.

6. Female participants of childbearing potential (defined as any female who has
experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral
tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at
least 12 consecutive months]) must agree to be heterosexually inactive OR consistently
use any of the following methods of contraception:

1. Condoms (male or female)

2. Diaphragm with spermicide

3. Cervical cap with spermicide

4. Intrauterine device

5. Oral or patch contraceptives

6. Any country regulatory-approved contraceptive method that is designed to protect
against pregnancy

7. Abstinence, as a form of contraception, is acceptable if in line with the
participant's lifestyle (other approaches to abstinence are not acceptable).

Exclusion Criteria:

1. Contraindications to commonly used vaccines;

2. History of allergy to any vaccines or drug;

3. Received any vaccine within 1 month before the first dose of vaccination；

4. Serious diseases required to be excluded, including but not limited to history of
diseases in nervous system, cardiovascular system, blood and lymphatic system, immune
system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones
and other systems, and a history of malignant tumors;

5. Before immunizing the first dose of investigational vaccine, those who developed acute
disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection
within 7 days;

6. Those who have a hereditary bleeding tendency or blood coagulation dysfunction, or a
history of thrombosis or hemorrhagic disease；

7. Surgical removal of whole or part of spleen for any reason；

8. Those who have undergone surgery within 3 months before signing the ICF or those who
plan to undergo surgery during or within 3 months after completion of the trial
(including plastic surgery, dental and oral surgery);

9. Those who donated or lost blood (≥400 mL) in the past 3 months, who received blood
transfusion or use of blood products, or who plan blood donation during the trial;

10. Those who received other investigational or unregistered products (drugs, vaccines,
biological product or devices) in the past 3 months before signing the ICF, or plan to
use them during the study.

11. Those who received immunosuppressant therapy within 6 months before signing the ICF,
such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid
therapy for more than 2 consecutive weeks within 6 months, such as prednisone or
similar drugs), but local administration is permitted (such as ointment, eye drops,
inhalants, or nasal spray). The local administration should not exceed the recommended
dose in the package insert or have any signs of systemic exposure;

12. Participants cannot meet the criteria through the comprehensive physical examination,
mainly including:

- Abnormal vital signs with clinical significance (awakening heart rate <55
beats/min or >100 beats/min, systolic blood pressure ≥140mmHg or diastolic blood
pressure ≥90mmHg);

- Those who tested positive for type 1 or type 2 human immunodeficiency virus
(HIV-1/2) antibody, or SARS-CoV-2 nucleic acid;

13. History of COVID-19;

14. Participants who have a positive pregnancy test, or are breastfeeding, or planning
pregnancy, or plan to donate sperm or eggs within 12 months from the screening period
to the whole-course immunization;

15. Participants who are considered as inappropriate for the trial by investigators.

16. Suspected or known current alcohol or drug dependency.

17. Investigator site personnel directly related to this study and/or their immediate
families; immediate family is defined as a spouse, parent, child, or sibling, whether
biological or legally adopted.