UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003639 |
|---|---|
| Receipt number | R000004408 |
| Scientific Title | Preventio of varicella zoster virus infection by immunization in aged patients with underlying diseases. |
| Date of disclosure of the study information | 2010/05/19 |
| Last modified on | 2012/10/10 22:20:09 |
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Basic information
Public title
Preventio of varicella zoster virus infection by immunization in aged patients with underlying diseases.
Acronym
Preventio of varicella zoster by immunization in aged underlying disease patients.
Scientific Title
Preventio of varicella zoster virus infection by immunization in aged patients with underlying diseases.
Scientific Title:Acronym
Preventio of varicella zoster by immunization in aged underlying disease patients.
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether a varicella-zoster virus specific immunity can be increased safely with the vaccine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
immunogenecity
Key secondary outcomes
development of zoster
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
From April 1 2010 to November 30 2010.
Interventions:Immunization with 1 dose of live attenuated Varicella vaccine (BIKEN) to 10 aged individuals.
Interventions/Control_2
From April 1 2010 to November 30 2010.
Interventions:Immunization with 1 dose of live attenuated Varicella vaccine (BIKEN) to 10 patients with diabetes mellitus.
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy aged individuals and diabetes mellitus patients controlled with
HbA1c 7-9.5.
Key exclusion criteria
Patients with malignant diseases or autoimmune diseases.
Patients with renal failure with sCr2.
Smoker.
Patients treated with steroid or aspirin.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hata Atsuko |
Organization
Kitano hospital, The Tazuke Kofukai Medical Research Institute
Division name
4th Division
Zip code
Address
2-4-20 Ohgimachi Kitaku Osaka
TEL
06-6312-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Satomi |
Organization
Kitano hospital, The Tazuke Kofukai Medical Research Institute
Division name
Clinical Research
Zip code
Address
2-4-20 Ohgimachi Kitaku Osaka
TEL
06-6312-1221
Homepage URL
rinshou@kitano-hp.or.jp
Sponsor or person
Institute
Kitano hospital,The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Mitsui Sumitomo Insurance Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Biomedical Innovation
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
田附興風会医学研究所 北野病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | 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
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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 19 | Day |
Last modified on
| 2012 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004408
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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