Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Adults (18-59 years old) A:They were randomly assigned to trial group and placebo group in a ratio of 4:1
Adults (18-59 years old) B:They were randomly assigned to trial group and placebo group in a ratio of 4:1
Adults (18-59 years old) C:They were randomly assigned to trial group and placebo group in a ratio of 4:1
Elderly group (>=60 years old) D:They were randomly assigned to trial group and placebo group in a ratio of 4:1
Elderly group (>=60 years old) E:They were randomly assigned to trial group and placebo group in a ratio of 4:1
Elderly group (>=60 years old) F:They were randomly assigned to trial group and placebo group in a ratio of 4:1
Sponsors
Hunan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. People aged 18 and above; 2. The subject has independent judgment, can read, understand and complete the vaccination diary card, and voluntarily participate in the vaccination and sign the informed consent form; 3. The subjects can comply with the requirements of the clinical trial protocol; 4. Armpit body temperature <=37.2 degree C; 5. No family planning (including partners of male subjects) in the first 3 months after enrollment; Effective contraceptive measures had been taken within 2 weeks before enrollment.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose: 1. People who have been to a foreign country or an infected village/community within 14 days prior to inoculation and have been in contact with NOVEL CORONAVIRUS infection or suspected case, who are in isolation, or who have been infected or suspected case in the same village/community; 2. Coronavirus infected with confirmed cases, suspected cases or asymptomatic infected persons; 3. Have been vaccinated with other COVID-19 vaccines before enrollment; 4. sarS-CoV-2 nucleic acid or antibody (IgG or IgM) positive results; 5. female pregnancy test positive, or breastfeeding; 6. A history of SARS or MERS virus infection; 7. Abnormal and clinically significant laboratory related indexes (prescribed indexes) before enrollment (except blood glucose); 8. Previous severe allergic reaction to vaccination or allergic to known ingredients (aluminum hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride) of the Novel coronavirus inactivated vaccine; 9. Have a history or family history of convulsions, epilepsy, encephalopathy and mental illness; 10. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 11. Within 3 days before inoculation, patients with acute disease or in the acute phase of chronic disease, or overuse of antipyretic analgesic and anti-allergy drugs; 12. Known or suspected medical conditions include: severe respiratory disease, severe cardiovascular disease, severe liver and kidney disease, medically uncontrolled hypertension (18-59 years: systolic blood pressure >=140mmHg or diastolic blood pressure >=90 mmHg; Systolic blood pressure >=160mmHg or diastolic blood pressure >=100 mmHg in subjects >=60 years old, diabetes (unstable blood glucose control, or failure of medication to control blood glucose, or diabetes complications), malignant tumor; 13. Has been diagnosed with congenital or acquired immunodeficiency, or is suspected of having a systemic disease that may interfere with the conduct or completion of the study, such as active tuberculosis, ongoing viral hepatitis, hiv-positive initial screening, syphilis infection (syphilitic specific antibody positive), etc. 14. There are contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy; 15. Received other research drugs within 6 months prior to vaccination; 16. Those who received immunobooster or inhibitor therapy within 3 months prior to vaccination (continuous oral or intravenous infusion for more than 14 days); 17. Received blood products (including but not limited to: immunoglobulin products, albumin products, clotting factor products, etc.) within 3 months prior to vaccination; 18. Have been vaccinated with live attenuated vaccine within 14 days prior to vaccination, or have been vaccinated with any vaccine other than live attenuated vaccine within 7 days prior to vaccination; 19. No spleen or abnormal spleen function; 20. The investigator determines that other conditions are not suitable for participation in the clinical trial. Exclusion criteria for the second dose: 1. Have received other COVID-19 vaccines after the first dose of exemption; 2. If the new findings meet the exclusion criteria, they are not suitable for follow-up inoculation after evaluation by researchers; 3. If any major disease occurs to the subject, it will cause additio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;Blood biochemical;Blood coagulation function;Urine routines;Urine pregnancy (for women of childbearing age only); | — |
Secondary
| Measure | Time frame |
|---|---|
| Humoral immunity (IgG, neutralizing antibody);cellular immunity; | — |
Countries
China
Contacts
Public ContactHuang Tao
Hunan Center for Disease Control and Prevention
Outcome results
None listed