| Trial registration number
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NCT04885907 |
Full text link
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04885907
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First author
Last imported at : June 10, 2021, 12:33 a.m.
Source : ClinicalTrials.gov
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Deepali Kumar, MD
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Contact
Last imported at : June 10, 2021, 12:33 a.m.
Source : ClinicalTrials.gov
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deepali.kumar@uhn.ca
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Registration date
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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2021-05-13
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Recruitment status
Last imported at : Aug. 3, 2022, 4:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- solid organ transplant recipient who has previously received moderna vaccine at 0 and
1 months
- able to provide informed consent
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Exclusion criteria
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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- anaphylaxis or allergic reaction to moderna vaccine
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Number of arms
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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University Health Network, Toronto
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Inclusion age min
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Canada
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Type of patients
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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High risk patients
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Severity scale
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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120
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primary outcome
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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anti-RBD antibody titer
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Notes
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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Phase 4
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Arms
Last imported at : May 29, 2021, 12:32 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "3rd dose;IM", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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