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| Column | Value |
|---|---|
| Trial registration number | NCT05398926 |
|
Full text link
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
not reported |
|
Registration date
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
2022-06-01 |
|
Recruitment status
Last imported at : Aug. 12, 2022, 5:30 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 3, 2022, 2 p.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 |
|
Study aim
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
inclusion criteria: subjects aged 60 years and above; provide legal identification; have completed two-dose of covid-19 vaccine (vero cell), inactivated manufactured by sinovac research& development co., ltd. for 3~6 months（the interval between two doses was 21~35 days）； be able to understand and voluntarily sign the informed consent form and be willing to complete the study according to the research plan. |
|
Exclusion criteria
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
history of sars-cov-2 infection(laboratory confirmed); those who have received covid-19 vaccine from other manufacturers other than sinovac research& development co., ltd., or who have received booster immunization with covid-19 vaccine after two doses of covid-19 vaccine (vero cell),inactivated manufactured by sinovac research& development co., ltd.; history of serious adverse reactions to the vaccine or vaccine components, such as urticaria dyspnea and angioneuroedema; 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) in the past 6 months or plan to receive these treatments during the study period; receipt of blood products within in the past 3 months or plan to receive these treatments during the study period; receipt of other investigational drugs in the past 30 days; receipt of attenuated live vaccines in the past 14 days,or receipt of inactivated or subunit vaccines in the past 7 days; onset of various acute or chronic diseases within 7 days prior to the study; axillary temperature >37.0°c; 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 : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : June 11, 2022, 4:30 p.m. Source : ClinicalTrials.gov |
Sinovac Life Sciences Co., Ltd. |
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Inclusion age min
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
60 |
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Inclusion age max
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
400 |
|
primary outcome
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Immunogenicity index- GMT of neutralizing antibodies;Immunogenicity index-GMT of neutralizing antibodies;Safety index-Incidence of adverse reactions |
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Notes
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
Phase 4 |
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Arms
Last imported at : June 3, 2022, 2 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "3-month interval", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "4-month interval", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5-month interval", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "6-month interval", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}] |