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| Column | Value |
|---|---|
| Trial registration number | NCT04953325 |
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Full text link
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : April 15, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : April 15, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
2021-07-07 |
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Recruitment status
Last imported at : April 15, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - healthy population aged 18 years and above; - the subjects can understand and voluntarily sign the informed consent form; - proven legal identity. |
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Exclusion criteria
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
- history of sars-cov-2 infection; - have received any covid-19 vaccine; - participants with abnormal fasting blood glucose or diabetes; - history of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema; - autoimmune disease or immunodeficiency / immunosuppression; - severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.; - severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; - thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition; - diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; - diseases or factors that are prone to thrombosis or bleeding, such as thrombophlebitis, major surgery/trauma, hereditary thrombotic disorder, sepsis, inflammatory bowel disease, severe varicose veins, may-thurner syndrome, fibrinolytic activity enhancement disease, history of cardiac stent surgery, allergic purpura, etc.; - immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; - abnormal hematological laboratory test results outside the reference range during previous physical examination within one year: blood routine indicators (white blood cell count, hemoglobin, platelet count), coagulation function test (prothrombin time pt, activated partial prothrombin time aptt, fibrinogen fib, thrombin time tt, international standardized ratio inr, d-dimer), other indicators (blood glucose, platelet factor 4 hit elisa, erythrocyte sedimentation rate); - history of alcohol or drug abuse; - receipt of blood products within in the past 3 months; - receipt of other investigational drugs in the past 30 days; - receipt of attenuated live vaccines in the past 14 days; - receipt of inactivated or subunit vaccines in the past 7 days; - axillary temperature >37.0°c; - already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months; - history of taking aspirin drugs and other drugs that affect blood coagulation; - according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. |
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Number of arms
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Sinovac Research and Development Co., Ltd. |
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Inclusion age min
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
270 |
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primary outcome
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 |
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Notes
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "600SU;2;Days0-28", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "25\u03bcg (day 0) + 600SU (day 28)", "treatment_id": 1671, "treatment_name": "Hepatitis a vaccine+pneumococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}] |