| Trial registration number
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TCTR20211023002 |
Full text link
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20211023002
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First author
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Wachiraporn Arunothong
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Contact
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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wachira_arun@yahoo.com
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Registration date
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-10-23
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Recruitment status
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : April 1, 2022, 1 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Single group assignment
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Masking
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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participants were adults aged more than 18 years who completed 2 doses of a three-week schedule of Verocell, and have not had SARS-CoV-2 infection.
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Exclusion criteria
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Participants were excluded from the study if they: had history of severe adverse or allergic reactions to previous vaccinations, were pregnancy or planned pregnancy within 4 weeks after vaccination, used of systemic or topical corticosteroids, had bleeding diathesis , received other Covid-19 vaccine, and had SARS-CoV-2 infection before collecting post ID injection blood sample.
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Number of arms
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1
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Funding
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Lampang Hospital
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Inclusion age min
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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40
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primary outcome
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Safety and tolerability immediate; 30 minutes; day 1; day 7; and day 30 Direct observe ; Vaccine side effect report form
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Notes
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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Arms
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "1;ID;have previously completed 2 doses of a three-week schedule of Verocell", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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