UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046185 |
|---|---|
| Receipt number | R000052712 |
| Scientific Title | Research for the efficacy of the workplace COVID-19 vaccinations |
| Date of disclosure of the study information | 2021/11/25 |
| Last modified on | 2023/02/17 12:34:08 |
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Basic information
Public title
Research for the efficacy of the workplace COVID-19 vaccinations
Acronym
Research of the workplace COVID-19 vaccinations
Scientific Title
Research for the efficacy of the workplace COVID-19 vaccinations
Scientific Title:Acronym
Research of the workplace COVID-19 vaccinations
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the acquisition of humoral and cellular immunity after Moderna COVID-19 vaccination at workplace.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the acquisition of humoral and cellular immunity for SARS-CoV-2
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
-Faculties, staffs and students of Keio University.
-Administered Moderna COVID-19 vaccine at workplace vaccination of Keio University
-Written informed consent obtained and suitable for peripheral blood sample collection.
Key exclusion criteria
-Under 18 years-old
-Not suitable for blood sample collection medically.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hasegawa |
Organization
Keio University
Division name
Department of Infectious Diseases, School of Medicine
Zip code
1608582
Address
35 Shinamomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3353-1211
covid-vaccine-research-group@keio.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Uwamino |
Organization
Keio University
Division name
Department of Laboratory Medicine, School of Medicine
Zip code
1608582
Address
35 Shinamomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3353-1211
Homepage URL
http://keio-vaccinestudy.com/
covid-vaccine-research-group@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
+81-3-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood samples, answers for questionnaire, medical record and health center record will be obtained from faculties, staffs and student of Keio University who were vaccinated Moderna COVID-19 vaccine at workplace vaccination of Keio University. The acquisition of Humoral and cellular immunity and incidence of adverse reactions will be investigated.
Management information
Registered date
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052712
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
