| Trial registration number
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NCT04911790 |
Full text link
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04911790
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First author
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Xiaoqiang Liu, Doctor
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Contact
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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lxq7611@126.com
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Registration date
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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2021-06-03
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Recruitment status
Last imported at : May 5, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Single group assignment
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Masking
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- have not received any covid-19 vaccine in the past or at least one dose of coronavac
manufactured by sinovac research and development co.,ltd;
- population aged 18 years and above;
- the subjects can understand and voluntarily sign the informed consent form and
participate in the follow-up;
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Exclusion criteria
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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- history of severe allergy to the vaccine such as acute allergic reaction,angioedema
and dyspnea ;
- severe neurological disease such as transverse myeliti,guillain-barre syndrome and
demyelinating disorders;
- acute diseas,acute onset of chronic disease and severe chronic diseases.
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Number of arms
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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1
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Funding
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Sinovac Research and Development Co., Ltd.
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Inclusion age min
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
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China
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Type of patients
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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121000
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primary outcome
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Safety index-incidence of adverse reactions
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Notes
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "600SU;Days0-28;IM", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]
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