| Trial registration number
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NCT05059106 |
Full text link
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05059106
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First author
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Valéria Valim, PhD
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Contact
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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val.valim@gmail.com
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Registration date
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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2021-09-28
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Recruitment status
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Sequential assignment
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Masking
Last imported at : Sept. 29, 2021, 8:30 a.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 : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- residents of viana, espírito santo, aged between 18 and 49 years
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Exclusion criteria
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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- pregnant women;
- history of severe allergic reaction (anaphylaxis) to any previously administered
vaccine;
- having received another vaccine in the last 14 days;
- belonging to a priority risk group for vaccination, as per the pni recommendations;
- have fever or flu-like symptoms;
- have previously received any vaccine for covid-19 at any time;
- recent diagnosis of covid-19 with onset of symptoms 28 days before vaccination;
- disorders of coagulation and use of anticoagulants.
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Number of arms
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Federal University of Espirito Santo
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Inclusion age min
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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49
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Countries
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Brazil
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Type of patients
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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29637
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primary outcome
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Incidence of new cases
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Notes
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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Phase 2/Phase 3
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Arms
Last imported at : Sept. 29, 2021, 8:30 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "Half dose; 2; 8 weeks", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Standard dose; 2; 8 weeks", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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