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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046185
Receipt No. 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 2021/11/25

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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
Email 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
Email covid-vaccine-research-group@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 21 Day
Date of IRB
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
2021 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.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


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