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| Column | Value |
|---|---|
| Trial registration number | TCTR20210904004 |
|
Full text link
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
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First author
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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Contact
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
suvimol.niy@mahidol.edu |
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Registration date
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2021-09-04 |
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Recruitment status
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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) |
RCT |
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Allocation
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
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Design
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Sequential assignment |
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Masking
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Open label |
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Center
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
single-center |
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Study aim
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Prevention |
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Inclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1. Males or females at least 18-60 years of age (inclusive) 2. Have not received any COVID-19 vaccine? 3. Can understand Thai language through speaking, reading and writing? 4. Able to communicate through electronic tools such as Google form or line? 5. Capable of attending all study visits according to the study schedule. 6. Capable of informed consent and provision of written informed consent before any study procedures. |
|
Exclusion criteria
Last imported at : June 2, 2022, 8 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1. Have history of severe drug or vaccine allergy (anaphylaxis)? 2. Have detected COVID-19 infection? 3. Have history of COVID-19 high risk contact? 4. Have history of Chronic respiratory disease, CVD, CKD, CVS, obesity, cancer and DM? 5. Positive result(s) from either antigen test kit. 6. Have received blood transfusion, plasma, blood product, blood component, immunoglobilins, antiviral or antibodies within the last 90 days? 7. Have history of cigarettes smoking, alcohol drinking and history of drug abuse? 8. Being pregnant? 9. have unstable disease or could not control the sysptom? 10. Have history of immunodeficiency or been using immunosuppressant or steriod drugs? 11. Have any unusual symptoms or medical history that considered unable to participate in the study? |
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Number of arms
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
4 |
|
Funding
Last imported at : June 2, 2022, 8 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Health Systems Research Institute (HSRI) |
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Inclusion age min
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
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Inclusion age max
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
60 |
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Countries
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Thailand |
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Type of patients
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Healthy volunteers |
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Severity scale
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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) |
40 |
|
primary outcome
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Immunological Response 2 wk and 12 wk after complete vaccination IgG level |
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Notes
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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Phase
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Phase 1/Phase 2 |
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Arms
Last imported at : Oct. 7, 2021, 9:30 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "2;Inactivated vaccine/ AstraZeneca", "treatment_id": 1985, "treatment_name": "Chadox1 ncov-19+inactivated covid-19 vaccine", "treatment_type": "Non replicating viral vector+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"}, {"arm_notes": "2", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;AstraZeneca/Pfizer", "treatment_id": 1443, "treatment_name": "Bnt162b2+chadox1 ncov-19", "treatment_type": "Rna based vaccine+non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |