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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018879
Receipt No. 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

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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
Email 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
Email infe@kitano-hp.or.jp

Sponsor
Institute Kitano hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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