Trial registration number
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JPRN-UMIN000045097 |
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=R000051522
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First author
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Shintaro Tanaka
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Contact
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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shintarou.tanaka@shionogi.co.jp
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Registration date
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-08-09
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Recruitment status
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Single group assignment
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Masking
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Exclusion criteria
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. For male, those who more than 200 mL of their whole blood or blood component has been lost within 12 weeks before consent acquisition, or those who more than 100 mL of their whole blood or blood component has been lost within 4 weeks before consent acquisition. For female, those who more than 200 mL of their whole blood or blood component has been lost within 16 weeks before consent acquisition, or those who more than 100 mL of their whole blood or blood component has been lost within 4 weeks before consent acquisition.2. Those who participated in other clinical studies within 30 days before consent acquisition, or are participating in other clinical studies except for ",Observational study on the evaluation of COVID-19 prevention and subjects', health status after SARS-CoV-2 vaccination", conducted by Shionogi &, Co., Ltd.
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Number of arms
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1
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Funding
Last imported at : Sept. 29, 2021, 7 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 : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Sept. 29, 2021, 7 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 : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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7380
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primary outcome
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Antibody titer for virus neutralization activity
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Notes
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}]
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