UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029176 |
|---|---|
| Receipt number | 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 10:13:10 |
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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
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
kamei-k@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033353
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
