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| Column | Value |
|---|---|
| Trial registration number | NCT05890521 |
|
Full text link
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
810173358@qq.com |
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Registration date
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
2023-06-06 |
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Recruitment status
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: healthy people or special people aged 18 and above who meet the requirements of national new coronavirus vaccination (including but not limited to obesity (bmi ≥ 28kg/ m²). chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc.); if the researcher determines that it is necessary, the special population shall provide relevant written diagnosis certificates, records or drug prescription certificates issued by doctors; the subjects voluntarily participated in the study, signed the informed consent, understood and complied with the requirements of the clinical trial scheme, and were able to understand the research procedures. |
|
Exclusion criteria
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
patients with uncontrolled lymphoproliferative diseases, unresponsive aplastic anemia, active primary immune thrombocytopenia (itp), uncontrolled bleeding and coagulation diseases, etc; people with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, guillain barre syndrome, demyelinating disease, etc.); patients suffering from acute disease, or acute attack of chronic disease, or uncontrolled severe chronic disease; previous history of severe allergy to any vaccine or any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, henoch schonlein purpura, thrombocytopenic purpura, dyspnea, angioneuroedema, etc; the researchers believe that the subject has any disease or condition that may put the subject at unacceptable risk; the subjects could not meet the protocol requirements; interference with the evaluation of vaccine response. |
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Number of arms
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
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Inclusion age min
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
100000 |
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primary outcome
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
AE;AESI;SAE |
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Notes
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : June 7, 2023, noon Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1088, "treatment_name": "Recombinant sars-cov-2 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |