| Trial registration number
|
TCTR20210920005 |
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/TCTR20210920005
|
First author
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Kriangkrai Tawinprai
|
Contact
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Kriangkrai.taw@pccms.ac.th
|
Registration date
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2021-09-20
|
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 : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. age 12-30 year old
2. no active underlying disease.
3. informed to participated the study.
|
Exclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. previous infection with SAR-CoV-2
2. previous received SAR-CoV-2 vaccine
3. receive any vaccine with 14 days
4. Fever at vaccination day
5. History of URI within 14 days
6. History of seizure.
7. Abnormal development
8. Pregnancy.
9. Lactation.
10. History of severe allergy to vaccine.
|
Number of arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2
|
Funding
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Chulabhorn Royal Academy
|
Inclusion age min
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
12
|
Inclusion age max
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
30
|
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)
|
500
|
primary outcome
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Geomatric mean ratio (GMR) of anti-RBD of SARS-CoV-2 between adolescent group and adult group 4 week after second shot Anti-RBD antibodies level
|
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 2
|
Arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "2;21 day apart (+7);IM (adult)", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;21 day apart (+7);IM (adolescent)", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]
|