UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056872 |
|---|---|
| Receipt number | R000065001 |
| Scientific Title | Vaccine effectiveness of COVID-19 vaccine in Japan |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2025/12/28 11:39:47 |
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Basic information
Public title
Vaccine effectiveness of COVID-19 vaccine in Japan
Acronym
Vaccine effectiveness of COVID-19 vaccine in Japan
Scientific Title
Vaccine effectiveness of COVID-19 vaccine in Japan
Scientific Title:Acronym
Vaccine effectiveness of COVID-19 vaccine in Japan
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of COVID-19 vaccine against symptomatic disease, hospitalization, and severe disease in older adults in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness of COVID-19 vaccine among adults aged 60 years or older in Japan.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had signs and symptoms consistent with COVID-19 and tested for SARS-CoV-2.
Key exclusion criteria
1. Patients who refused to participate through opt-out.
2. Patients whose COVID-19 vaccination history is unknown.
Target sample size
5000
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
852-8523
Address
1-12-4 Sakamoto, Nagasaki city, Nagasaki, 852-8523,Japan
TEL
095-819-7842
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
852-8523
Address
1-12-4 Sakamoto, Nagasaki city, Nagasaki, 852-8523,Japan
TEL
095-819-7842
Homepage URL
mharuka@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Meiji Seika Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 03 | 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 | 11 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 SARS-CoV-2 vaccines in Japan by using a test-negative design.
Management information
Registered date
| 2025 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065001
