| Trial registration number
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NCT05689177 |
Full text link
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05689177
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First author
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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None
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Contact
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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None
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Registration date
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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2023-01-19
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Recruitment status
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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nonRCT
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Allocation
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Non-randomized
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Design
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Single group assignment
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Masking
Last imported at : Jan. 20, 2023, 8 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 : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
age 18-80 y.o.;
more that 4 months after the previous vaccination against covid-19;
no covid-19 infection registered within 30 days prior to soberana plus administration.
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Exclusion criteria
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
|
age less than 18 y.o. or more than 80 y.o.;
less than 4 months after the previous vaccination against covid-19;
covid-19 infection registered within 30 days prior to soberana plus administration.
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Number of arms
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Gomel State Medical University
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Inclusion age min
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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80
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Countries
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Belarus
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Type of patients
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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100
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primary outcome
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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IgG level assessment;IgG level assessment;IgG level assessment
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Notes
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Jan. 20, 2023, 8 a.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Feb. 1, 2023, 4 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "Participants 18-25 y.o.", "treatment_id": 513, "treatment_name": "Finlay-fr-1a anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Participants 26-80 y.o.", "treatment_id": 513, "treatment_name": "Finlay-fr-1a anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]
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