| Trial registration number
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JPRN-UMIN000044519 |
Full text link
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050864
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First author
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Hisamitsu Ishihara
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Contact
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nakayama.tomohiro@nihon-u.ac.jp
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Registration date
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-06-13
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Recruitment status
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Exclusion criteria
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Those who have requested refusal to participate in this research2. In addition, those who the principal investigator deems inappropriate as research subjects3. When this research is discontinued by the entire organization conducting the research4. Those who have an urgent and obvious life threat to the research subject Of the above (1) target patients, those who meet all of the (2) selection criteria and do not meet any of the (3) exclusion criteria are eligible.
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Number of arms
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Nihon University School of Medicine Itabashi Hospital
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Inclusion age min
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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16
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Inclusion age max
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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40
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primary outcome
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Subject's present illness; past history; life history1. Basic information of research subjects: age; gender; diagnosis name; family history; medical history; drug treatment history; allergy history; fever; height; weight; body mass index; physical findings; symptoms2. Presence or absence of symptoms at the time of vaccination;3. Laboratory dataSARS-CoV-2 IgG antibody; IgM antibody; viral genome genotypeLeukocytes; CRP; AST; ALT; LD; ALP; gamma GT; IgG; IgE; IgA; IgM
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Notes
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : June 17, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]
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