UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of practical application of micro-needle type influenza vaccine
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Asada Hideo
Organization	Nara Medical University
Division name	Dept of Dermatology
Address	840 Shijyo-cho Kashihara
TEL	0744-22-3051
Email	asadah@naramed-u.ac.jp

Public contact
Name of contact person	Azukizawa Hiroaki
Organization	Nara Medical Univ
Division name	Dept of Dermatology
Address	840 Shijyo-cho Kashihara
TEL	0744-22-3051
Homepage URL
Email	azukizaw@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000024129