UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055893 |
|---|---|
| Receipt number | R000063874 |
| Scientific Title | Vaccine effectiveness of respiratory infectious diseases in Japan |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2024/10/21 10:45:00 |
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Basic information
Public title
Vaccine effectiveness of respiratory infectious diseases in Japan
Acronym
Vaccine effectiveness of respiratory infectious diseases in Japan
Scientific Title
Vaccine effectiveness of respiratory infectious diseases in Japan
Scientific Title:Acronym
Vaccine effectiveness of respiratory infectious diseases in Japan
Region
| Japan |
Condition
Condition
COVID-19, Flu
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to evaluate vaccine effectiveness of COVID-19 vaccines and flu vaccines against symptomatic diseases, hospitalizations, and severe diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effectiveness of COVID-19 vaccine and flu vaccine will be assessed using a test-negative design case-control study (partially using a case-control study) in individuals 18 years of age or older who visit medical facilities with symptoms of suspected respiratory tract infection and in individuals 60 years of age or older who are hospitalized with symptoms of suspected respiratory tract infection.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals 18 years of age or older who visit medical facilities with symptoms of suspected respiratory tract infection and individuals 60 years of age or older who are hospitalized with symptoms of suspected respiratory tract infection.
Key exclusion criteria
Those refusing to participate in the study
Those with an unknown history of COVID-19 vaccination and an unknown history of flu vaccination
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Maeda |
Organization
Institute of Tropical Medicine, Nagasaki University
Division name
Department of Respiratory Infections
Zip code
8528523
Address
1-12-4 Sakamoto, Nagasaki
TEL
0958197842
mharuka@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Maeda |
Organization
Institute of Tropical Medicine, Nagasaki University
Division name
Department of Respiratory Infections
Zip code
8528523
Address
1-12-4 Sakamoto, Nagasaki
TEL
0958197842
Homepage URL
https://www.tm.nagasaki-u.ac.jp/versus/
mharuka@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board at Institutional of Tropical Medicine at Nagasaki University
Address
1-12-4 Sakamoto, Nagasaki city, Nagasaki, 852-8523,Japan
Tel
095-819-7803
soum-nekken@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本国内17施設
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to evaluate the effectiveness of COVID-19 vaccines and flu vaccinesin Japan by using a test-negative design.
Management information
Registered date
| 2024 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063874
