Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
inactivated vaccine group:Novel Coronavirus inactivated vaccine (Vero cell)
control group:Nil
Sponsors
Shanghai Oriental Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Request medical history and physical examination, and the researchers judged health status of subjects; 2. Aged 18 to 60 years; 3. BMI 18.5-30Kg/m2; 4. Novel Coronavirus (COVID-19) antibodies (IgG, IgM) are negative; 5. Female subjects with childbearing age are not pregnant at the time of admission (negative reaction in urine pregnancy test); 6. Armpit temperature <=37 degree C; 7. The Subjects are able to comply with the study and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of convulsion, epilepsy, Guillain Barre syndrome, encephalopathy or mental illness or family history; 2. Fever (armpit temperature > 37.0 degree C) before vaccination; 3. Subjects with history of severe allergic reactions (such as anaphylactic shock, acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of vaccine; 4. Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, malignant tumors; 5. Subjects with various acute diseases, uncontrollable severe chronic disease, acute onset of chronic diseases or fever; 6. Subjects with abnormal indicators, such as blood biochemistry, blood routine and urine routine, which might show clinical meaning, before administration; 7. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 8. Female Subjects in pregnancy, lactation or have a family planning within 3 months; 9. Subjects receiving the immunosuppressive therapy, glucocorticoids, antiallergic or cytotoxic therapy within 6 months; 10. Subjects vaccinated with live attenuated vaccine within 1 month, or other vaccine within 14 days before vaccination; 11. Subjects receiving blood products within 3 months before administration; 12. Subjects receiving other research drugs within 6 months before vaccination; 13. The researchers shall judge the other conditions which might be not in compliance with the reequipments of this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events;Adverse reactions;blood biochemistry;blood routine;Coagulation function index;urine routine;HbA1c;neutralizing antibody;specific antibody; | — |
Countries
China
Contacts
Public ContactZhongming Liu
Shanghai Oriental Hospital
Outcome results
None listed