UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011168 |
|---|---|
| Receipt number | R000013081 |
| Scientific Title | Evaluation of necessity, safety and clinical effctiveness of unlicesed vaccine for travelers and patient in Japan. |
| Date of disclosure of the study information | 2013/07/11 |
| Last modified on | 2014/01/11 10:02:32 |
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Basic information
Public title
Evaluation of necessity, safety and clinical effctiveness of unlicesed vaccine for travelers and patient in Japan.
Acronym
Clinical evaluation of necessity, safety and effctiveness of unlicesed vaccine in Japan.
Scientific Title
Evaluation of necessity, safety and clinical effctiveness of unlicesed vaccine for travelers and patient in Japan.
Scientific Title:Acronym
Clinical evaluation of necessity, safety and effctiveness of unlicesed vaccine in Japan.
Region
| Japan |
Condition
Condition
Travelers and immunocopromised host who need vaccination unlicensed vaccine
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the necessity, safety and effectiveness of unlicesed vaccine in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ask the participants about adverse reactions and disease prevention.
Key secondary outcomes
Base
Study type
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
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
People who need unlicensed vaccine for travel or underlying disease
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
| 5 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who come to infectious department in Kobe University Hospital. And physician think that vaccination is necessary and there is no contraindication for the vaccination.
Key exclusion criteria
People has contraindication for the vaccine and has previous history of Guillain-Barre syndrome
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goh Ohji |
Organization
Kobe Univesity Hospital
Division name
Infectious Disease
Zip code
Address
7-5-2, Kusunokicho, Cyuoku, Kobe
TEL
078-382-5111
ohji@sanynet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goh Ohji |
Organization
Kobe University Hospital
Division name
Infectious Disease
Zip code
Address
7-5-2, Kusunokicho, Chuoku, Kobe
TEL
078-382-5111
Homepage URL
ohji@sanynet.ne.jp
Sponsor or person
Institute
Division of Infectious Disease Therapeutics, Department of Infectious Diseases and Microbiology, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2014 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013081
