Novel coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Control group:placebo
Group 1:Inactivated SARS-CoV-2 vaccine (Vero cell)
Group 2:Inactivated SARS-CoV-2 vaccine (Vero cell)
Sponsors
China National Biotec Group Co.Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age range: Healthy subjects aged 18 years old and above 2. By asking for medical history and physical examination, the investigator judged that the health condition is well. 3. 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; 4. During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan. With self-ability to understand the research procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.
Exclusion criteria
Exclusion criteria: 1. SARS-CoV-2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection; 2. SARS-CoV-2 Nucleic acid test positive; 3. Have a history of SARS, MERS infection (self-report, on-site inquiry); 4. Fever (axillary temperature > 37.0 degree C), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination; 5. Axillary body temperature >37.0 degree C before vaccination; 6. 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; 7. Have a history of convulsion, epilepsy, encephalopathy or mental illness or family history; 8. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 9. Severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure >=140 mmHg, diastolic blood pressure >= 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attack period of chronic diseases; 10. Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 11. Diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors; 12. History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease); 13. Receiving anti-TB therapy; 14. Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days); 15. Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination; 16. Received blood products within 3 months before this vaccination; 17. Received other research drugs within 6 months before this vaccination; 18. Investigator judged other circumstances that are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protective efficacy against COVID 19; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the protective effect14 days after 2 doses of immunization of preventing severe cases of SARS-CoV-2 pneumonia and deaths accompanied by COVID-19.;incidene of adverse reactions/events;incidene of adverse reactions/events;Incidence of Serious Adverse Events (SAE);Four-fold growth rate and antibody level (GMT, GMI) of serum antibody against COVID-19; | — |
Countries
The Arab Republic of Egypt
Contacts
Public ContactDr. Nawal Al Kaabi
Shaikh Khalifa Medical City
Outcome results
None listed