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| Column | Value |
|---|---|
| Trial registration number | NCT05029245 |
|
Full text link
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
2021-08-31 |
|
Recruitment status
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
unclear |
|
Study aim
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: signed informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. men and women, ≥18 years of age at time of enrollment. able to follow up the vaccination schedule. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
patient with known hypersensitivity or intolerance to comirnaty® or polyethylene glycol (peg). patient with previous receiveing mrna vaccine ( pfizer, moderna or other). pregnancy with gestational age less than 12 weeks. patient with history of immunosuppessive drug ( oral , iv, im ) of which discontinue less than 6 month or any immunological abnormality which impact to antibody production and t cell function ( eg hypergammaglobulinemia, active immne deficiency). patient with previous used of intravenous immunoglobulin in previous 6 month patient with history of abnormal coagulation or contraindication for intramuscular injection or intradermal injection. patient with end stage disease or disease with life expectancy less than 2 years patient with previous use of medication interfere with serum interferon other cytokine system or disease with cytokine abnormalities. patient with history of abnormal platelet or platelet dysfunction, blood coagulopathy abnormality. patient with active pulmonary tuberculosis or systemic tuberculosis, atypical non mycobacterium tuberculosis. |
|
Number of arms
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
8 |
|
Funding
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Rajavithi Hospital |
|
Inclusion age min
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Interferon gamma level;Level of Anti RBD antibody |
|
Notes
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Sept. 1, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "6 ug;2;Days0-28;ID;history of Coronavac vaccine 2 dosage at least 1 month before enrollment ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 ug;2;Days0-28;IM;history of Coronavac vaccine 2 dosage at least 1 month before enrollment ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "6 ug;2;Days0-28;ID;history of ChAdOX1 Cov-19 vaccine 2 dosage at least 1 month before enrollment ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 ug;2;Days0-28;IM;history of ChAdOX1 Cov-19 vaccine 2 dosage at least 1 month before enrollment ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "6 ug;2;Days0-28;ID;no history SAR-CoV vaccine before enrollment ", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 ug;2;Days0-28;IM;no history SAR-CoV vaccine before enrollment", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "6 ug;2;Days0-28;ID;any history of vaccination with Anti-RBD< 650AU/ml at least 1 month before enrollment", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 ug;2;Days0-28;any history of vaccination with Anti-RBD< 650AU/ml at least 1 month before enrollment", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |