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| Column | Value |
|---|---|
| Trial registration number | NCT05911061 |
|
Full text link
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
None |
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Registration date
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
2023-06-20 |
|
Recruitment status
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
inclusion criteria: subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects. basic or booster immunization with covid-19 vaccine ≥6 months. ≥3 months of sars-cov-2 infection history, or never infected. have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols. |
|
Exclusion criteria
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
axillary temperature ≥37.3℃. sars-cov-2 antigen or nucleic acid screening positive within the last 48 hours. anti-sars-cov-2 igm antibody was positive during the screening period. it is in the advanced stage of malignant tumor and the disease control is unstable. female pregnancy (pregnancy test results are positive), lactation period. have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs. have other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions. have been diagnosed with congenital or acquired immunodeficiency, hiv infection. people who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past. congenital or acquired angioedema/neuroedema. asplenia or functional asplenia. thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications). received another investigational drug within 1 month prior to receiving the investigational vaccine. received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month. fertile female subjects did not use effective contraception within 1 month prior to enrollment. fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization. abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine. medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent. |
|
Number of arms
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
WestVac Biopharma Co., Ltd. |
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Inclusion age min
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
4950 |
|
primary outcome
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
AE and AR;Efficacy against COVID-19 |
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Notes
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : June 21, 2023, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "High dose ", "treatment_id": 2744, "treatment_name": "Recombinant covid-19 trivalent (xbb+ba.5+delta) vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Low dose", "treatment_id": 2744, "treatment_name": "Recombinant covid-19 trivalent (xbb+ba.5+delta) vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Active Comparator", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |