| Trial registration number
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TCTR20210308003 |
Full text link
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20210308003
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First author
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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saovanee Benjamanukul
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Contact
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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saovanee.ben@gmail.com
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Registration date
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-03-08
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Recruitment status
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Center
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. Healthy Thai adults aged between 18-60 years
2. Willing to be immunized with COVID-19 vaccine
3. Intend to be available for follow-up visits and phone call through 12 months postvaccination
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Exclusion criteria
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. Subjects with history of COVID-19, asymptomatic SARS-CoV-2 infection or pre-existing antibodies to SARS-CoV-2
2. Previous severe reaction or allergy to any components in the COVID-19 vaccine
3. History of hospitalization within the past one month before injection.
4. Serious underlying medical condition (e.g., immunosuppressive disease or receiving immunosuppressive therapy, human immunodeficiency virus (HIV) infection)
5. Pregnant women, lactating women or women who are planning to become pregnant
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Number of arms
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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National Reseach Council; Thailand
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Inclusion age min
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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60
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Countries
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : March 26, 2021, 2:21 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 : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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185
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primary outcome
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Immunogenicity 3 months Antibodies against SARS-COV-2
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Notes
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : March 26, 2021, 2:21 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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Arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "2", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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