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Trial - JPRN-UMIN000043769


Column Value
Trial registration number JPRN-UMIN000043769
Full text link
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Keiichi Tsukinoki

Contact
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

tsukinoki@kdu.ac.jp

Registration date
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-03-30

Recruitment status
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

nonRCT

Allocation
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Non-randomized

Design
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Single group assignment

Masking
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

unclear

Study aim
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Exclusion criteria
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

History of new coronavirus

Number of arms
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1

Funding
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Kanagawa Dental University

Inclusion age min
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

24

Inclusion age max
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

65

Countries
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Japan

Type of patients
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Health workers

Severity scale
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

40

primary outcome
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Specimen search items; saliva S protein-specific sIgA; saliva S protein-specific IgG; S protein-specific IgM in saliva is measured by ELISA. The search method is as follows: (1) Perform a PCR test to detect SARS-CoV-2 in all search subjects and confirm that it is negative. Next; (2) collect saliva with saliva. Search before; 1 month and 6 months after vaccination.

Notes
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : April 23, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "No information on previous doses", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]