UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018879 |
|---|---|
| Receipt number | R000021834 |
| Scientific Title | Efficacy and safety of live varicella vaccine in patients with diabetes mellitus associated with decreased cell-mediated immunity: a Randomized, Double-blind, Placebo-controlled Trial |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2019/03/25 15:48:59 |
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Basic information
Public title
Efficacy and safety of live varicella vaccine in patients with diabetes mellitus associated with decreased cell-mediated immunity: a Randomized, Double-blind, Placebo-controlled Trial
Acronym
Efficacy and safety of live varicella vaccine in patients with diabetes: a Randomized, Double-blind, Placebo-controlled Trial
Scientific Title
Efficacy and safety of live varicella vaccine in patients with diabetes mellitus associated with decreased cell-mediated immunity: a Randomized, Double-blind, Placebo-controlled Trial
Scientific Title:Acronym
Efficacy and safety of live varicella vaccine in patients with diabetes: a Randomized, Double-blind, Placebo-controlled Trial
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate varicella zoster virus (VZV)-specific cell-mediated immunity live attenuated Oka varicella zoster vaccine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
varicella zoster virus-specific cell-mediated immunity by using an interferon-g enzyme-linked immunosorbent assay at 3, 6 and 12 months after primary administration of vaccine or placebo.
Key secondary outcomes
immunogenicity of varicella vaccine at 3, 6 and 12 months after primary administration of vaccine or placebo.
safety of varicella vaccine for 12 months after after primary administration of vaccine or placebo.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
A: saline+saline
Interventions/Control_2
B: varicella vaccine+saline
Interventions/Control_3
C: varicella vaccine+varicella vaccine
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
diabetic patients with HbA1c(JDS) 6-9.5%
Diabetic patients diagnosed by a physician based on the Report of the Committee on the Classification and Diagnostic Criteria of Diabetes Mellitus(J Diabetes Investig.1:212-28. 2010).
Key exclusion criteria
Excluded were users of steroids or other immunosuppressive drugs, those with heart disease treated by antiplatelet drugs, immunocompromised patients with any potential malignant disease, autoimmune disease, renal failure, patients with immunization of varicella vaccine within 5 years, HZ patients, andsmokers,
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Hata |
Organization
Kitano hospital, The Tazuke Kofukai Medical Research Institute
Division name
Department of Infectious Diseases
Zip code
5308480
Address
2-4-20 Ohgimachi Kitaku Osaka
TEL
06-6312-8824
ahata@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Hata |
Organization
The Tazuke Kofukai Medical Research Institute
Division name
department of infectious diseases
Zip code
5308480
Address
2-4-20 Ohgimachi Kitaku Osaka
TEL
06-6312-1221
Homepage URL
infe@kitano-hp.or.jp
Sponsor or person
Institute
Kitano hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitano hospital, The Tazuke Kofukai Medical Research Institute
Address
2-4-20 Ohgimachi Kitaku Osaka Japan
Tel
06-6312-1221
rinshou@kitano-hp.or.jp
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
| 2015 | Year | 09 | Month | 01 | 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
| 2015 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 24 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 12 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021834
| 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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