| Trial registration number
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TCTR20210517006 |
Full text link
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20210517006
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First author
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Kriangkrai Tawinprai
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Contact
Last imported at : June 12, 2021, 12:45 a.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 : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-05-17
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Recruitment status
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. 18 years old or more
2. negative for blood SARS-CoV-2 antibody
3. negative for nasopharynx PCR for SARS-CoV-2
4. Negative urine pregnancy test (in case of potential of pregnancy)
5. No history of a severe allergic reaction to the prior vaccine.
6. No fever nor history of fever within 14 days.
7. No symptom of respiratory tract infection within 14 days.
8. ECOG 0,1
9. sign informed consent to the study.
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Exclusion criteria
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. prior COVID-19 vaccination.
2. Vaccination with any vaccines within 30 days
3. administration of steroid or receive immunoglobulins within 30 days
4. Receive immunosuppression agent within 30 days.
5. pregnancy.
6. lactation.
7. acute coronary syndrome in the past year.
8. Acute stroke in the past year.
9. Splenectomy
10. active chronic infectious disease.
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Number of arms
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3
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Funding
Last imported at : June 12, 2021, 12:45 a.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 : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3000
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primary outcome
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Antibody level of total antibody of spike protein of SARS-CoV-2 1 month after the second 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 : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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Arms
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "2;3 week interval;IM", "treatment_id": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;3 week interval;IM", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;12 week interval;IM", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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