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| Column | Value |
|---|---|
| Trial registration number | NCT05165966 |
|
Full text link
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
2021-12-21 |
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Recruitment status
Last imported at : Aug. 12, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Blind 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 : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: healthy participants aged 18 years and above; proven legal identity; the subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan; have received two doses of inactivated covid-19 vaccine (coronavac®) manufactured by sinovac research & development co., ltd and that is currently 5-9 months after the second dose. |
|
Exclusion criteria
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
history of sars-cov-2 infection(laboratory confirmed); have received three and more doses of inactivated covid-19 vaccine; known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema; autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as aids, post-transplant; 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; diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; 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; acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination; axillary temperature >37.0°c; participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period; according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial. |
|
Number of arms
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Aug. 12, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Sinovac Life Sciences Co., Ltd. |
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Inclusion age min
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
340 |
|
primary outcome
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) |
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Notes
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : Dec. 23, 2021, 3:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Medium dose;600SU", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High dose 1200SU", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |