UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018479 |
|---|---|
| Receipt number | R000021366 |
| Scientific Title | Clinical Study using serum samples obtained in clinical trial of absorbed influenza vaccine(2) |
| Date of disclosure of the study information | 2015/08/03 |
| Last modified on | 2015/07/29 16:01:50 |
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Basic information
Public title
Clinical Study using serum samples obtained in clinical trial of absorbed influenza vaccine(2)
Acronym
Clinical Study using serum samples obtained in clinical trial of absorbed influenza vaccine(2)
Scientific Title
Clinical Study using serum samples obtained in clinical trial of absorbed influenza vaccine(2)
Scientific Title:Acronym
Clinical Study using serum samples obtained in clinical trial of absorbed influenza vaccine(2)
Region
| Japan |
Condition
Condition
side effect of influenza vaccine
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study measure serum micro RNA of the clinical study subjects and analyze correlation with side effect and antibody titer, aiming to search the mechanisms of side effect and predictable biomarker.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of microRNA in serum sample of the vaccine trial subjects.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 0 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who are the subject of the vaccine clinical trial and who agree to participate this study
Key exclusion criteria
Not obtained the agreement
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Ishii |
Organization
National Institutes of Biomedical Innovation,Health and Nutrition
Division name
Laboratory of Adjuvant Innovation
Zip code
Address
7-6-8 Asagi Saito Ibaraki-City Osaka
TEL
072-641-8043
kenishii@biken.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Ishii |
Organization
National Institutes of Biomedical Innovation,Health and Nutrition
Division name
Laboratory of Adjuvant Innovation
Zip code
Address
7-6-8 Asagi Saito Ibaraki-City Osaka
TEL
072-641-8043
Homepage URL
kenishii@biken.osaka-u.ac.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation,Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Daiichi Sankyo Company
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
| 2015 | Year | 08 | Month | 03 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
sample usage
Approximately 500 microL of each serum will be used for measurement of micro RNA.
analysis
Comparisons would be done between serum microRNA and clinical status.
Management information
Registered date
| 2015 | Year | 07 | Month | 29 | Day |
Last modified on
| 2015 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021366
