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Trial - TCTR20210910002


Column Value
Trial registration number TCTR20210910002
Full text link
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

https://www.thaiclinicaltrials.org/show/TCTR20210910002

First author
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Yong Poovorawan

Contact
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

yong.p@chula.ac.th

Registration date
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-09-10

Recruitment status
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

nonRCT

Allocation
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Non-randomized

Design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Healthy Thai individuals above 18 years Have never been infected with COVID-19

Exclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Immunosuppressed conditions

Number of arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

11

Funding
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

The Health Systems Research Institute

Inclusion age min
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Thailand

Type of patients
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Healthy volunteers

Severity scale
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

420

primary outcome
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

antibody response 1 month post booster dose IgG

Notes
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 4

Arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "full dose (third dose);individuals who received 2 doses of CoronaVac vaccines 3 or 6 months ago", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "half dose (third dose);individuals who received 2 doses of CoronaVac vaccines 3 or 6 months ago", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "full dose (third dose);individuals who received 2 doses of CoronaVac vaccines 3 or 6 months ago", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "half dose (third dose);individuals who received 2 doses of CoronaVac vaccines 3 or 6 months ago", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "full dose (third dose);individuals who received 2 doses of CoronaVac vaccines 3 or 6 months ago", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "half dose (third dose);individuals who received 2 doses of CoronaVac vaccines 3 or 6 months ago", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "full dose (third dose);individuals who received 2 doses of CoronaVac vaccines 3 or 6 months ago", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "full dose (third dose);individuals who received 2 doses of ChAdOx1 nCoV-19 vaccines (at 6 months post first dose)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "half dose (third dose);individuals who received 2 doses of ChAdOx1 nCoV-19 vaccines (at 6 months post first dose)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "full dose (third dose);individuals who received 2 doses of ChAdOx1 nCoV-19 vaccines (at 6 months post first dose)", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "half dose (third dose);individuals who received 2 doses of ChAdOx1 nCoV-19 vaccines (at 6 months post first dose)", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]