| Trial registration number
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JPRN-jRCT2031210470 |
Full text link
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://jrct.niph.go.jp/latest-detail/jRCT2031210470
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First author
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Corporate Communications Department -
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Contact
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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shionogiclintrials-admin@shionogi.co.jp
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Registration date
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-12-06
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Recruitment status
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Participant must be >= 20 years of age inclusive, at the time of signing the informed consent.Participant who have received 2 doses of COMIRNATY and at least 6 months post second dose.
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Exclusion criteria
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Positive SARS-CoV-2 antigen test result at Screening.A known history of SARS-CoV-2 infection as determined by medical interview before study intervention.Participant has a contraindication to IM injections or blood draws.
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Number of arms
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Nagata Tsutae
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Inclusion age min
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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204
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primary outcome
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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SARS-CoV-2 neutralizing antibody titer on Day 29
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Notes
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2/Phase 3
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Arms
Last imported at : Jan. 13, 2022, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "1;IM", "treatment_id": 1139, "treatment_name": "S-268019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1;IM", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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