| Trial registration number
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IRCT20210620051639N2 |
Full text link
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/59156
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First author
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Jafar Salimian
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Contact
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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jafar.salimian@gmail.com
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Registration date
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-10-11
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Recruitment status
Last imported at : Dec. 11, 2021, 2:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
Prevention
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Inclusion criteria
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
Healthy persons, 18-40 years old,
Without uncontrolled underlying disease
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Exclusion criteria
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
History of Covid-19 disease in the past month, positive coronavirus PCR test, uncontrolled underlying disease, T Important surgical history, receiving corona vaccine
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Number of arms
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
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Funding
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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Bagheiat-allah University of Medical Sciences
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Inclusion age min
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
40
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Countries
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
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Type of patients
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
Healthy volunteers
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Severity scale
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
N/A
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Total sample size
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
300
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primary outcome
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
IgG antibody against Receptor Binding Domain (RBD) protein
Cellular immunity response against recombinant vaccine RBD protein
Measurement of neutralizing Antibody based on virus neutralizing test (VNT)
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Notes
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 2
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Arms
Last imported at : Oct. 11, 2021, noon
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "80\u00b5g;3;days0-21-35;IM", "treatment_id": 1920, "treatment_name": "Noora", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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