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Trial - TCTR20210731004


Column Value
Trial registration number TCTR20210731004
Full text link
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

https://www.thaiclinicaltrials.org/show/TCTR20210731004

First author
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Kriangkrai Tawinprai

Contact
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Kriangkrai.taw@pccms.ac.th

Registration date
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-07-31

Recruitment status
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

nonRCT

Allocation
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Non-randomized

Design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

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. No history of a severe allergic reaction to the prior vaccine. 3. No fever nor history of fever within 14 days. 4. No symptoms of respiratory tract infection within 14 days. 5. Received two doses of COVID-19 vaccine for at least 3 months 6. sign informed consent to the study.

Exclusion criteria
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. pregnancy. 2. lactation. 3. History of SARS-CoV-2 infection

Number of arms
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

6

Funding
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Chulabhorn Royal Academy

Inclusion age min
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Thailand

Type of patients
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Healthy volunteers

Severity scale
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

5520

primary outcome
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Humoral immunity 4 weeks after third dose 4 weeks after the third dose of the vaccine Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2

Notes
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 2

Arms
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "Coronavac (D1, D2) Booster Bbibp-corv 0.5ml", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Coronavac (D1, D2) Booster ChAdOx1 nCov-19 0.5ml", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Coronavac (D1, D2) Booster BNT162b2 0.5ml", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "ChAdOx1 nCov-19 (D1, D2) Booster Bbibp-corv 0.5ml", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "ChAdOx1 nCov-19 (D1, D2) Booster ChAdOx1 nCov-19 0.5 ml", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "ChAdOx1 nCov-19 (D1, D2) Booster BNT162b2 0.5 ml", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]