UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of efficacy and risks of vaccination for liver transplant recipients
Acronym	Vaccination for liver transplant recipients
Scientific Title	Evaluation of efficacy and risks of vaccination for liver transplant recipients
Scientific Title:Acronym	Vaccination for liver transplant recipients
Region	Japan

Condition
Condition	Liver transplant recipients
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and risks of vaccination for liver transplant recipients with immunosuppressant
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Obtain immunity from vaccination 12 months after vaccination (IgG)
Key secondary outcomes	Side effects of vaccination within 12months after vaccination

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Vaccine
Interventions/Control_1	Vaccination for patients with immunosuppressant measles rubella mumps varicella each 1 time
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	2 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	More than 2 years after transplantation Without steroid administration More than 1 year with stable liver functional tests
Key exclusion criteria	Without inclusion criteria With active infection
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name OKAJIMA
Organization	Graduate School of Medicine Kyoto University
Division name	Division of Hepato-Biliary-Pancreatic surgery
Zip code	606-8507
Address	54 Kawaracho Shogoin Sakyo-ku Kyoto, JAPAN
TEL	075-751-3243
Email	ho1962@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name OKAJIMA
Organization	Graduate School of Medicine Kyoto University
Division name	Division of Hepato-Biliary-Pancreatic surgery
Zip code	606-8507
Address	54 Kawaracho Shogoin Sakyo-ku Kyoto, JAPAN
TEL	075-751-3243
Homepage URL
Email	ho1962@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto Unoversity
Address	Kawaharacho-54 Shogoin Sakyo-ku Kyoto, JAPAN
Tel	075-751-3243
Email	ho1962@kuhp.kyoto-u.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

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 20 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	Terminated
Date of protocol fixation	2018 Year 12 Month 13 Day
Date of IRB	2017 Year 12 Month 20 Day
Anticipated trial start date	2018 Year 12 Month 20 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 20 Day
Last modified on	2019 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034751