| Trial registration number
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JPRN-jRCT2031210613 |
Full text link
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://jrct.niph.go.jp/latest-detail/jRCT2031210613
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First author
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Contact
Last imported at : March 4, 2022, 2 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 : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-02-17
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Recruitment status
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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nonRCT
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Allocation
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Non-randomized
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Design
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Single group assignment
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Masking
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : March 4, 2022, 2 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 SARS-CoV-2 vaccine (Adults:only SPIKEVAX, Older adults: COMIRNATY or SPIKEVAX) and 6 months or more and 8 months or less after second dose.
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Exclusion criteria
Last imported at : March 4, 2022, 2 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 : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1
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Funding
Last imported at : March 4, 2022, 2 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 : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : March 4, 2022, 2 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 : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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150
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primary outcome
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Safety
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Notes
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : March 4, 2022, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1139, "treatment_name": "S-268019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]
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