| Trial registration number
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JPRN-UMIN000045492 |
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=R000051936
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First author
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Yohei Seki
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Contact
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Shokuiki_antibody@shionogi.co.jp
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Registration date
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-09-16
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Recruitment status
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Single group assignment
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Masking
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Exclusion criteria
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Participants who have been confirmed to have a history of SARS-CoV-2 infection.2. A loss of >, 200 mL of whole blood or blood components within 12 weeks or >, 100 mL within 4 weeks of the first dose of study intervention in male participants. A loss of >, 200 mL of whole blood or blood components within 16 weeks or >, 100 mL within 4 weeks of the first dose of study intervention in female participants.3. Current enrollment or past participation within the last 30 days before signing of ICF in any other clinical study involving an clinical study or any other type of medical research.4. Participants who have been confirmed to be positive in human immunodeficiency virus (HIV) antigen/antibody test, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody test result.
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Number of arms
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1
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Funding
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Shionogi & Co.; Ltd.
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Inclusion age min
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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0
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Inclusion age max
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Oct. 21, 2021, 10 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 : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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120
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primary outcome
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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SARS-CoV-2 neutralizing antibody titerAnti-spike protein IgG antibody titerCellular immunity (cytokine-producing cell count)
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Notes
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Oct. 21, 2021, 10 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"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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