UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018695 |
|---|---|
| Receipt number | R000021482 |
| Scientific Title | Evaluation of Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay |
| Date of disclosure of the study information | 2015/08/17 |
| Last modified on | 2019/03/25 15:43:33 |
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Basic information
Public title
Evaluation of Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay
Acronym
Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay
Scientific Title
Evaluation of Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay
Scientific Title:Acronym
Varicella Zoster Virus specific immune response assessed by IFN-g releasing assay
Region
| Japan |
Condition
Condition
healthy adult, 20 to 75 years of age
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish methods for evaluating changes IFN-g releasing from mononuclear cells of subjects with immunization of Varicella zoster vaccine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
rate of change of IFN-g after vaccination of varicella vaccine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
varicella vaccine live attenuated "BIKEN"
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults, male or female
Key exclusion criteria
Vaccination inappropriate person : A person under any of the following condition is not able to be vaccinated.
1. A person who has a fever
2. A person appear suffering severe acute illness
3. A person who previously exhibited anaphylaxis by components of this varicella vaccine
4. A pregnant woman
5. In addition to the persons listed above, a person who is in an inappropriate state for vaccination
Target sample size
17
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
06-6131-2889
Homepage URL
infe@kitano-hp.or.jp
Sponsor or person
Institute
The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
The Tazuke Kofukai Medical Research Institute Ethics Committee
Address
2-4-20 Ohgimachi Kitaku Osaka 530-8480 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 | 08 | Month | 17 | 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 | 07 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 17 | 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=R000021482
