| Trial registration number
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TCTR20210714003 |
Full text link
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20210714003
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First author
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Kriangkrai Tawinprai
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Contact
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Kriangkrai.taw@pccms.ac.th
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Registration date
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-07-14
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Recruitment status
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. 18 years old or more 2. Negative urine pregnancy test (in case of potential of pregnancy) 3. No history of a severe allergic reaction to the prior vaccine. 4. No fever nor history of fever within 14 days. 5. No symptoms of respiratory tract infection within 14 days. 6. sign informed consent to the study.
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Exclusion criteria
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. prior COVID-19 vaccination. 2. pregnancy. 3. lactation.
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Number of arms
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3
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Funding
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Chulabhorn Royal Academy
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Inclusion age min
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Sept. 1, 2021, 11 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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264
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primary outcome
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Humoral immunity 4 weeks after boosted dose 4 weeks after the boosted dose of the vaccine Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2
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Notes
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
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Phase
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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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": "heterologous coronavac/Chadox1 ncov-19;2;4 week interval;IM", "treatment_id": 1444, "treatment_name": "Chadox1 ncov-19+coronavac", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "heterologous Chadox1 ncov-19/coronavac;2;4 week interval;IM", "treatment_id": 1444, "treatment_name": "Chadox1 ncov-19+coronavac", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "homologous;2;8 week interval;IM", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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