UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045107 |
|---|---|
| Receipt number | R000051520 |
| Scientific Title | Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2023/08/08 16:48:05 |
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Basic information
Public title
Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination
Acronym
Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination
Scientific Title
Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination
Scientific Title:Acronym
Observational study on the evaluation of COVID-19 prevention and subjects' health status after SARS-CoV-2 vaccination
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conduct a questionnaire survey for participants, who are employee and their family members, with or without vaccination in order to evaluate SARS-CoV-2 vaccine's long-term preventive effect in Japan.
In addition, we conduct a questionnaire survey after SARS-CoV-2 vaccination in order to evaluate participants' health status after SARS-CoV-2 vaccination.
Further, we evaluate the relation between serum neutralizing antibody titer and SARS-CoV-2 infection by analyzing with the result from "Prospective study on evaluation of immunological response after SARS-CoV-2 vaccination" which we conduct parallelly.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 positive rate at 6-months
Key secondary outcomes
The following endpoints at 3, 6, 9, and 12 months:
- SARS-CoV-2 positive rate (except for 6 month as this is defined as the primary endpoint)
- COVID-19 incidence rate
- Incidence rate of COVID-19-related symptoms
- Rate of subjects in each COVID-19 infection severity
- Household transmission rate
- Incidence rate of symptoms which were observed after SARS-CoV-2 vaccination
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Employee and their family members in Shionogi & Co. Ltd. (including its group companies) and other companies who can perform evaluation by application by themselves.
2) Employee and their family members in Shionogi & Co. Ltd. (including its group companies) and other companies who consented to this study by their own will with substantial understanding of this research by reading through ICF.
3) Employee and their family members in Shionogi & Co. Ltd. (including its group companies) and other companies with either of the following condition:
(A) Those who are vaccinated for SARS-CoV-2.
The 1st vaccination was performed less than 6 months before of obtaining their consent.
(B) Those who have not been vaccinated for SARS-CoV-2.
They are not applied for or will not be vaccinated by November 2021.
4) Those who can download the application for this study and enter the data through the application.
Key exclusion criteria
Those who do not consent to this study
Target sample size
8200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kunishima |
Organization
St. Marianna University
Division name
Department of Infectious Diseases
Zip code
216-8511
Address
2-16-1 Sugao Miyamaeku Kawasaki city, Kanagawa, Japan
TEL
044-977-8111
h2kuni@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Tanaka |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs Department
Zip code
100-0005
Address
1-8-2, Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-5219-7306
Homepage URL
shintarou.tanaka@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & 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
Non-Profit Organization MINS Research Ethics Committee
Address
5-20-9-401, Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2021 | Year | 08 | Month | 10 | 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
829
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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051520
