UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020943 |
|---|---|
| Receipt number | R000024129 |
| Scientific Title | Study of practical application of micro-needle type influenza vaccine |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2016/04/08 12:00:16 |
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Basic information
Public title
Study of practical application of micro-needle type influenza vaccine
Acronym
Study of micro-needle type influenza vaccine
Scientific Title
Study of practical application of micro-needle type influenza vaccine
Scientific Title:Acronym
Study of micro-needle type influenza vaccine
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
development of the new patch-type vaccine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective symptoms, Inspection findings, blood test, antibody titer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine | Maneuver |
Interventions/Control_1
SC injection of influenza vaccine
Interventions/Control_2
inoculation with microneedle patch-type influenza vaccine
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
according to inoculation standard of inactivated vaccine
Key exclusion criteria
according to inoculation standard of inactivated vaccine
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asada Hideo |
Organization
Nara Medical University
Division name
Dept of Dermatology
Zip code
Address
840 Shijyo-cho Kashihara
TEL
0744-22-3051
asadah@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Azukizawa Hiroaki |
Organization
Nara Medical Univ
Division name
Dept of Dermatology
Zip code
Address
840 Shijyo-cho Kashihara
TEL
0744-22-3051
Homepage URL
azukizaw@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
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
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
| 2016 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | 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
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2016 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024129
