UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043534 |
|---|---|
| Receipt number | R000049704 |
| Scientific Title | Preventive effectiveness and safety of vaccination against nosocomial outbreaks of COVID-19 |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2022/03/07 16:07:07 |
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Basic information
Public title
Preventive effectiveness and safety of vaccination against nosocomial outbreaks of COVID-19
Acronym
The covid vaccine for an outbreak of COVID-19 in a hospital
Scientific Title
Preventive effectiveness and safety of vaccination against nosocomial outbreaks of COVID-19
Scientific Title:Acronym
The covid vaccine for an outbreak of COVID-19 in a hospital
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the vaccination against COVID-19, in addition to preventive measures against the spread of infection, is effective and safe as personal and herd immunity in a hospital during a nosocomial outbreak of COVID-19.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse reactions
Key secondary outcomes
Adverse events and safety endpoints
COVID-19 infection
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
Participants are eligible for this study if they work at Tsukuba Memorial Hospital.
Those who do not refuse to participate in this study.
Key exclusion criteria
Participants deemed ineligible as study participants by the research director
Target sample size
1030
Research contact person
Name of lead principal investigator
| 1st name | Toshikazu |
| Middle name | |
| Last name | Abe |
Organization
Tsukuba Memorial Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
300-2622
Address
1187-299 Kaname, Tsukuba, Ibaraki, 300-2622, Japan
TEL
+81-29-864-1212
abetoshi111@gmail.com
Public contact
Name of contact person
| 1st name | Toshikazu |
| Middle name | |
| Last name | Abe |
Organization
Tsukuba Memorial Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
300-2622
Address
1187-299 Kaname, Tsukuba, Ibaraki, 300-2622, Japan
TEL
+81-29-864-1212
Homepage URL
abetoshi111@gmail.com
Sponsor or person
Institute
Tsukuba Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Memorial Hospital Institutional Review Board
Address
1187-299 Kaname, Tsukuba, Ibaraki, 300-2622, Japan
Tel
+81-4-7092-2211
ma.iijima@tsukuba-kinen.or.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
| 2021 | Year | 03 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exposure: BNT162b2 mRNA Covid-19 Vaccine
Variables: Patients demographics, adverse reaction, adverse events, COVID-19 infection, safety endpoints, infection ratio in a facility
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2022 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049704
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
