UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007502 |
|---|---|
| Receipt number | R000007673 |
| Scientific Title | A clinical study of microneedle vaccination with influenza virus |
| Date of disclosure of the study information | 2012/03/14 |
| Last modified on | 2012/03/14 13:19:53 |
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Basic information
Public title
A clinical study of microneedle vaccination with influenza virus
Acronym
A clinical study of microneedle vaccination with influenza virus
Scientific Title
A clinical study of microneedle vaccination with influenza virus
Scientific Title:Acronym
A clinical study of microneedle vaccination with influenza virus
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Infectious disease | Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical study is aimed to verify safety and tolerability of microneedle vaccination with influenza virus
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elevation of serum IgG, IgA, IgM titer against influenza hemmagglutinin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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 |
Interventions/Control_1
microneedle vaccination with influenza hemmagglutinin
Interventions/Control_2
conventional subcutaneous injection with influenza hemmagglutinin
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
heathy male 20-65 years old
Key exclusion criteria
female, people who had allergy for influenza vaccination, people who have fever on the day of administration
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Azukizawa |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
2-2, Yamadaoka, Suita, 565-0871 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
2-2,Yamadaoka, Suita, 565-0871 JAPAN
TEL
06-6879-3031
Homepage URL
Sponsor or person
Institute
Department of Dermatology, Osaka University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health Labour Sciences Research Grants
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
| 2012 | Year | 03 | Month | 14 | 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
| 2011 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 14 | Day |
Last modified on
| 2012 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007673
