| Trial registration number
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TCTR20211220004 |
Full text link
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20211220004
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First author
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Theerada Assawasaksakul
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Contact
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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theerada.azza@gmail.com
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Registration date
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-12-20
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Recruitment status
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Single group assignment
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Masking
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Age 18-65 years old Diagnosis of SLE according to American College of Rheumatology (ACR) 1997 or The Systemic Lupus International Collaborating Clinics (SLICC) criteria or or EULAR/ACR classification Diagnosis of RA according to 2010 ACR and European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis, who have been vaccinated with either inactivated SARS-CoV-2 or viral-vector ChAdOx1 nCoV-19 COVID-19 vaccine
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Exclusion criteria
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Pregnancy, History of SARS-CoV-2 infection
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Number of arms
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1
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Funding
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Ratchadapiseksompotch Fund; Faculty of Medicine
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Inclusion age min
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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65
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Countries
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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High risk patients
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Severity scale
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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primary outcome
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Immunogenicity outcomes Day 15 Humoral immune response;Immunogenicity outcomes Day 15 Cellular immune response;Safety and reactogenicity outcomes Within 14 days Frequency and grade of AEs
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Notes
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "have been vaccinated with either inactivated SARS-CoV-2 or viral-vector ChAdOx1 nCoV-19 COVID-19 vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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