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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029176
Receipt No. R000033353
Scientific Title National survey of live attenuated vaccines for patients using immunosuppressive or biological agents
Date of disclosure of the study information 2017/09/19
Last modified on 2019/06/30

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Basic information
Public title National survey of live attenuated vaccines for patients using immunosuppressive or biological agents
Acronym National survey of live vaccines
Scientific Title National survey of live attenuated vaccines for patients using immunosuppressive or biological agents
Scientific Title:Acronym National survey of live vaccines
Region
Japan

Condition
Condition Patients using immunosuppressive or biological agents
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Nephrology
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of live attenuated vaccines for patients using immunosuppressive or biological agents, we planed the national survey of institutes in which pediatric patients of renal, rheumatic, hepatic or digestive disease or organ transplant recipients are followed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes As this study is observational study, we did not decide the primary outcomes.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients of either of renal, rheumatic, liver or digestive disease or organ transplant recipients using immunosuppressive or biological agents who received live-attenuated vaccines.
Key exclusion criteria none
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Kamei
Organization National Center for Child Health and Development
Division name Division of Nephrology and Rheumatology
Zip code 157-8535
Address 2-10-1, Okura, Setagaya-ku, Tokyo
TEL 03-5494-7128
Email kamei-k@ncchd.go.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Kamei
Organization National Center for Child Health and Development
Division name Division of Nephrology and Rheumatology
Zip code 157-8535
Address 2-10-1, Okura, Setagaya-ku, Tokyo
TEL 03-5494-7128
Homepage URL
Email kamei-k@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization None
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 Ethical committee of National Center for Child Health and Development
Address 2-10-1, Okura, Setagaya-ku, Tokyo
Tel 0334160181
Email None

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
2017 Year 09 Month 19 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 781
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
2017 Year 09 Month 15 Day
Date of IRB
2017 Year 09 Month 07 Day
Anticipated trial start date
2017 Year 09 Month 15 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We had finished the national survey.

Management information
Registered date
2017 Year 09 Month 17 Day
Last modified on
2019 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033353

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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