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| Column | Value |
|---|---|
| Trial registration number | NCT05013983 |
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Full text link
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
462371198@qq.com |
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Registration date
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
2021-08-20 |
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Recruitment status
Last imported at : April 25, 2024, 8 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - aged 6-17 years； - the subject and/or guardian can understand and voluntarily sign the informed consent form (double signature is required for 8-17 years old)； - reproductive women have a negative pregnancy test before each vaccination； - the subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 13.5 months. |
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Exclusion criteria
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
- history of sars-cov-2 infection. - the covid-19 antibody (igg and igm) screening was positive. - history of asthma, history of allergy to vaccines or vaccine components, or severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioedema. - congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. - autoimmune diseases or immunodeficiency/immunosuppression. - severe chronic diseases that cannot be controlled by drugs, severe cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc. - severe neurological disease (epilepsy, convulsions or convulsions) or mental illness. - any condition caused by thyroid disease or history of thyroidectomy, hypersplenism, or splenectomy. - diagnosis of abnormal blood clotting function (for example, lack of clotting factors, coagulopathy, abnormal platelets) or obvious bruising or blood clotting. - in the past 6 months, received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis). - laboratory test results with clinically significant abnormalities (severity level 2 and above) (applicable to phase i clinical trials only). - received blood products in the last 3 months. - receive other study drugs or vaccines within the past 30 days. - vaccination against live attenuated vaccines in the past 30 days. - inactivated vaccine or subunit vaccine in the past 14 days. - acute disease or acute exacerbation of chronic disease in the last 7 days. - axillary temperature> 37.0°c. - according to the judgment of the investigator, the subject has other factors that are not suitable for participating in the clinical trial. subsequent dose |
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Number of arms
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
5 |
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Funding
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
WestVac Biopharma Co., Ltd. |
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Inclusion age min
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
6 |
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Inclusion age max
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
17 |
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Countries
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
600 |
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primary outcome
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Phase I clinical trial：The incidence of adverse reactions (ARs) .;Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.;Phase II clinical trial：The geometric mean titer(GMT) of specific antibody.;Phase II clinical trial：The incidence of adverse reactions (ARs) . |
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Notes
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
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Arms
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Low-dose vaccine (6-11 years)", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Medium-dose vaccine (6-11 years)", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Medium-dose vaccine (12-17 years)", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High-dose vaccine (12-17 years)", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |