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| Column | Value |
|---|---|
| Trial registration number | NCT04962308 |
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Full text link
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
wj81732@hotmail.com |
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Registration date
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
2021-07-14 |
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Recruitment status
Last imported at : June 4, 2023, 4 a.m. Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 15, 2021, 6 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 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
inclusion criteria: healthy adults aged 18-59; have been received two doses of inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research & development co., ltd at an interval of 21 to 31 days for group a.have been vaccination two doses of inactivated sars-cov-2 vaccine(coronavac)manufactured by sinovac research & development co., ltd for group b; the subjects can understand and voluntarily sign the informed consent form; proven legal identity. |
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Exclusion criteria
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
history of sars-cov-2 infection; any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated sars-cov-2 vaccine; severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination); 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; immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before primary immunization and before booster immunization; already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results) receipt of attenuated live vaccines within 14 days prior to booster vaccination; receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination; acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination; axillary temperature >37.0°c prior to booster vaccination; 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 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Sinovac Research and Development Co., Ltd. |
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Inclusion age min
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
59 |
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Countries
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
1400 |
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primary outcome
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2;Safety index-incidence of adverse reactions |
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Notes
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : July 15, 2021, 6 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Booster;1;3 months after completion of 2nd dose (safety group)", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster;1;3 months after completion of 2nd dose", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster;1;5 months after completion of 2nd dose", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |