| Trial registration number
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TCTR20220212001 |
Full text link
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20220212001
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First author
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Nasamon Wanlapakorn
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Contact
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nasamon.w@chula.ac.th
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Registration date
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-02-12
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Recruitment status
Last imported at : May 5, 2022, 11:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Healthy children between 5-11 years of age
2. No history of COVID-19 infection
3. Parents or guardians live in Bangkok and give informed consent to participate
4. Children between 7-11 years of age give informed assent to participate
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Exclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. History of COVID-19 infection
2. Immunocompromised status
3. Bleeding tendency (contraindicated to blood drawing)
4. History of COVID-19 vaccine allergy or severe reaction from vaccine
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Number of arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Chulalongkorn University
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Inclusion age min
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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5
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Inclusion age max
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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11
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Countries
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : March 11, 2022, 3:30 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 : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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120
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primary outcome
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Immunogenicity 28 days post two doses Anti-RBD IgG
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Notes
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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Arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1966, "treatment_name": "Bnt162b2+coronavac", "treatment_type": "Rna based vaccine+inactivated virus", "pharmacological_treatment": "Vaccine"}]
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