UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007710
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kamei-k@ncchd.go.jp

Sponsor
Institute Department of Nephrology and Rheumatology
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
Address
Tel
Email

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
URL(English) https://upload.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


Contact us.