| Trial registration number
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JPRN-jRCT2071210086 |
Full text link
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://jrct.niph.go.jp/latest-detail/jRCT2071210086
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First author
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Contact for Clinical Trial Information
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Contact
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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dsclinicaltrial@daiichisankyo.co.jp
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Registration date
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-10-29
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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 : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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unclear
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Study aim
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1) Japanese2) Healthy adults aged >=20 and <65 years at the time of informed consent 3) Body Mass Index (BMI) is >=17.5 and <30.0 kg/m^2 (at screening )4) Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc
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Exclusion criteria
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1) Having a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination.2) Having alcohol or drug dependence.3) Having a history of immunodeficiency or having a close relative with congenital immunodeficiency.4) Having a history of SARS-CoV-2 infection.5) Having fever of >=39.0 C or symptoms of suspected anaphylaxis such as systemic rash within 2 days after past vaccination.etc.
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Number of arms
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Inoguchi Akihiro
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Inclusion age min
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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20
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Inclusion age max
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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65
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Countries
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Japan
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Type of patients
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Dec. 30, 2021, 7:30 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 : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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80
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primary outcome
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Safety: Adverse events; specific adverse events; laboratory data; weight; vital signs and 12-lead ECGs
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Notes
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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Arms
Last imported at : Dec. 30, 2021, 7:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "30\u03bcg;2;IM", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "60\u03bcg;2;IM", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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