COVID-19
Conditions
Interventions
Experimental group:Experimental vaccine
placebo control group:placebo saline solution
positive control group:Novel coronavirus inactivated vaccine (vero cells)
Sponsors
Shulan(Hangzhou)Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) The age at the time of the first dose of vaccine was 18-59 years old in the adult group, =60 years old in the elderly group, regardless of gender (2) According to the medical history and physical examination, the investigator determined that the patient was in good physical condition (3) People who have not received the COVID-19 vaccine or =6 months after receiving 2 or 3 doses of 2019-NCoV vaccine (4) Participants who had not been infected with COVID-19 before or =1 month after negative nucleic acid test after infection (5) Participants who had used effective contraception within 2 weeks before enrollment (6) Participants or by the client has the ability to understand the research program, the informed consent, voluntarily signed the informed consent, to comply with the requirements of clinical research plan
Exclusion criteria
Exclusion criteria: (1) Childbearing age female in pregnancy test positive pregnancy and lactation, or have a pregnancy plan within 12 months; Male: whose spouse plans to become pregnant within 1 year (2) Has a history of epilepsy seizures or convulsions with psychosis or family history (3) Participants who were taking antipyretic, analgesic and anti-allergic drugs within 3 days before enrollment (4) Have a history of allergy to any drugs or vaccines (such as acute allergic reaction, urticaria, eczema, dyspnea, angioedema, or abdominal pain, etc.) or to known ingredients of the novel coronavirus vaccine (5) A history of hospital-diagnosed thrombocytopenia or other clotting disorders (6) Participants with known immune impairment or hypofunction diagnosed by the hospital (7) Participantss who had received immune-enhancing or immunosuppressive therapy (continuous oral or instillation for more than 14 days) within 3 months or whole blood, plasma, and immunoglobulin within 1 month (8) Known or suspected concurrent serious diseases including but not limited to: respiratory diseases, acute infections or active chronic diseases, liver and kidney diseases, severe diabetes, malignant tumors, infectious or allergic skin diseases, severe cardiovascular diseases diagnosed in hospital, and HIV infection (test report available) (9) Participants had a variety of acute diseases or were in the acute phase of a chronic disease within 3 days prior to vaccination (10) During the screening period, abnormal blood biochemistry, blood routine, urine routine, coagulation function, thyroid function, myocarditis related indexes were detected and had clinical significance (11) Received live attenuated vaccine within 1 month prior to vaccination (12) Received inactivated vaccine within 14 days prior to vaccination (13) Armpit temperature =37.3? (14) Participants who participated in other clinical trials within 3 months prior to receiving the first dose of vaccine or plan to participate in other clinical trials during the study period (15) Other conditions deemed inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local/systemic adverse reactions/events occurred 0-14 days and 15-28 days after each dose of immunization, and adverse events were collected within 14 days after each dose of immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| SAE from the first dose to 12 months after full immunization;4-fold growth rate of anti-SARS-CoV-2 neutralizing antibody, GMT and GMI at 14 and 28 days after full immunization;4-fold growth rate, GMT and GMI of anti-SARS-COV-2 neutralizing antibodies at 90, 180 and 360 days after full immunization; | — |
Countries
China
Contacts
Public ContactGuiling Chen
Shulan(Hangzhou)Hospital
Outcome results
None listed