| Trial registration number
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TCTR20220112002 |
Full text link
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20220112002
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First author
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prasert Assantachai
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Contact
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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prasert.uts@mahidol.ac.th
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Registration date
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-01-12
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Recruitment status
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
1. Aged 65 years old or more. 2. Having a 2-dose primary series of ChAdOx1 (AstraZeneca) vaccine for 12-24 weeks. 3. Stable and well-controlled chronic diseases. 4. Ability to understand and communicate in Thai language. 5. Ability to attend the appointment. 6.Ability to give informed consent
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Exclusion criteria
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Having a history of anaphylaxis to drug or other vaccines. 2. Having a previous history of Covid-19 infection or high-risk of Covid-19 infection. 3. Having any type of vaccination 2 week before the recruitment. 4. Having any type of immunodeficiency. 5. Taking any type of immunosuppressive agent or cytotoxic drug. 6. No acute illness or acute inflammation. 7. Having blood transfusion or other blood products, immunoglobulin, antiviral agent, or antibody within previous 90 days.
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Number of arms
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Faculty of Medicine Siriraj Hospital; Mahidol University
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Inclusion age min
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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65
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Inclusion age max
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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210
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primary outcome
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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vaccine adverse event 7 days number of adverse event
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Notes
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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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": "0.1 ml mRNA vaccine intradermal injection", "treatment_id": 1153, "treatment_name": "Sars-cov-2 mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.3-0.5 ml mRNA vaccine intramuscular injection", "treatment_id": 1153, "treatment_name": "Sars-cov-2 mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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