| Trial registration number
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NCT05133609 |
Full text link
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05133609
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First author
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Valéria Valim, PhD
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Contact
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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val.valim@gmail.com
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Registration date
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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2021-11-24
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Recruitment status
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Sequential assignment
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Masking
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
age 18 years or older
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Exclusion criteria
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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pregnant women;
history of severe adverse reaction to any previously administered vaccine;
having received another vaccine in the last 30 days.
the criteria for vaccination in the immune-mediated inflammatory diseases (imid) group will be in accordance with the ministry of health's national immunization program (pni/ms).
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Number of arms
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Federal University of Espirito Santo
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Inclusion age min
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Brazil
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Type of patients
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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550
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primary outcome
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Viral Neutralization Assay;Viral Neutralization Assay
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Notes
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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Phase 1/Phase 2
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Arms
Last imported at : Nov. 25, 2021, 9 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "3, day 0, day 84, and day 252, IM, health workers", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3, day 0, day 84, and day 252, IM, high risk patients", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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