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| Column | Value |
|---|---|
| Trial registration number | IRCT20210303050558N1 |
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Full text link
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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First author
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
biglari63@hotmail.com |
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Registration date
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2021-04-24 |
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Recruitment status
Last imported at : May 20, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
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Study design
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
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Allocation
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
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Design
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
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Masking
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Blind label |
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Center
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
multi-center |
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Study aim
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Prevention |
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Inclusion criteria
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Giving written informed consent Ability to comply with the vaccination plan, scheduled visits and lab tests Having general health and controlled underlying diseases Iranian citizenship Residing in the studied cities (Isfahan, Babol, Bandar Abbas, Zanjan, Kerman, Hamedan, Yazd and Sari) Both Genders Aged 18 to 80 years |
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Exclusion criteria
Last imported at : Nov. 8, 2021, 3:35 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Pregnant or lactating women or those who plan to become pregnant up to 3 months after the last dose of the vaccine Application of vaccines containing tetanus toxoid in the last 3 months History of blood /blood products transfusions such as immunoglobulin in the last three months Type 2 diabetes ( HbA1c higher than 7.5) Chronic liver disease (liver enzymes more than 5 times normal: ALT≥150, AST≥100) Subjects previously vaccinated against SARS-CoV-2. History of psychiatric disorders Uncontrolled asthma (having an asthma attack in the last three months). History of severe allergic reaction (anaphylaxis) to the vaccine throughout life History of smoking more than 20 cigarettes a day for more than twenty years Coagulation problems that contraindicate IM injection Previous vaccination with any coronavirus vaccine or participation in other COVID-19 vaccine trials Treatment with immunomodulators in the last 30 days Uncontrolled hypertension (cytological pressure more than 140, diastolic pressure more than 90 mm Hg) Fever or acute illness for 7 days before the injection or on the day of the injection Chronic kidney disease (GFR less than 30) All individuals who are in phase one priority of vaccination based on the National COVID-19 Vaccination Program (health workers can participate if they give consent) Subjects with tattoos in the deltoid region on both arms |
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Number of arms
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
3 |
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Funding
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Pasture Institute of Iran |
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Inclusion age min
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 |
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Inclusion age max
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
80 |
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Countries
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
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Type of patients
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Healthy volunteers |
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Severity scale
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
N/A |
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Total sample size
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
24000 |
|
primary outcome
Last imported at : Nov. 8, 2021, 3:35 p.m. Source : Iranian Registry of Clinical Trials (IRCT) |
The effectiveness of the vaccine in preventing symptomatic Covid-19 infection |
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Notes
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Phase
Last imported at : April 25, 2021, 1 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 3 |
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Arms
Last imported at : June 24, 2021, 2:30 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "25 \u03bcg;2;Days0-28", "treatment_id": 515, "treatment_name": "Finlay-fr-2 anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "three doses;Days 0-28-56;booster at day 56 is finlay-fr-1a (50 \u03bcg)", "treatment_id": 1519, "treatment_name": "Finlay-fr-1a anti-sars-cov-2 vaccine+finlay-fr-2 anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |