UMIN-CTR Clinical Trial

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
Email	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
Email	abetoshi111@gmail.com

Sponsor
Institute	Tsukuba Memorial Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049704