UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007710 |
|---|---|
| Receipt number | R000009090 |
| Scientific Title | Prospective study about immunization of attenuated live vaccines in children receiving immunosuppressants |
| Date of disclosure of the study information | 2012/04/13 |
| Last modified on | 2018/04/15 10:07:42 |
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Basic information
Public title
Prospective study about immunization of attenuated live vaccines in children receiving immunosuppressants
Acronym
Study about live vaccines in children receiving immunosuppressants
Scientific Title
Prospective study about immunization of attenuated live vaccines in children receiving immunosuppressants
Scientific Title:Acronym
Study about live vaccines in children receiving immunosuppressants
Region
| Japan |
Condition
Condition
Patients under treatment of immunosuppressants (CsA, FK, MZR, NNF, AZP)
Classification by specialty
| Gastroenterology | Nephrology | Infectious disease |
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the efficacy and safety of immunization with attenuated live vaccines in patients receiving immunosuppressants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Analysis of antibody acquisition after vaccination classified by each virus.
2) Analysis of maintenance of acquired immunity classified by each virus especially after 1 year.
3) Analysis of incididence of adverse events classified by each virus.
Key secondary outcomes
1) Analysis of causes of vaccine failure.
2) Analysis of causes of adverse events.
3) Analysis of effect for prevention of virus infection.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Live attenuated vaccine
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Equal or more than one years old.
2. Patients under treatment of immunosuppressants (CsA, FK, MZR, MMF, AZP, MTX)
3. Negative or borderline antibody titer of one or more of the following viruses: measles, rubella, varicella, or mumps.
4. Patients who cannot discontinue immunosuppressants because of primary disease.
5. Inactive primary disease.
6. Normal cellular immunity (CD4 counts>500/mm3, PHA lymphocyte stimulatory test-stimulation index>101.6).
7. Serum IgG level>300mg/dl
8. FK trough level<10ng/ml or CsA trough level<100ng/ml.
9. Approved by the committee for attenuated live vaccination in children receiving immunosuppressants.
Key exclusion criteria
1. Steroid use of more than 1mg/kg/d.
2. For renal transplant recipients, <1 year since transplantation or acute rejection within the previous 6 months.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Kamei |
Organization
National Center for Child Health and Development
Division name
Nephrology and Rheumatology
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
+81-3-5494-7128
kamei-k@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Kamei |
Organization
National Center for Child Health and Development
Division name
Nephrology and Rheumatology
Zip code
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
+81-3-5494-7128
Homepage URL
kamei-k@ncchd.go.jp
Sponsor or person
Institute
Department of Nephrology and Rheumatology
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
Address
Tel
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
| 2012 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 10 | Day |
Last modified on
| 2018 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009090
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/10/14 | 研究計画書20161122.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/10/14 | 接種回数 n=169 201105-201701.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/10/14 | 接種回数 n=169 201105-201701.xlsx |
