UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of microRNA using stored serum of subjects in clinical trial of influenza vaccine which was added AdvaxTM
Title of the study (Brief title)	Study of microRNA using stored serum of subjects in clinical trial of influenza vaccine which was added AdvaxTM
Region	Japan Australia

Condition
Condition	Influenza
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to search biomarker correlated with the safety and efficacy of AdvaxTM as a new adjuvant ,and to aim elucidation of function of adjuvant and vaccine in vivo.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MicroRNA expression change in serum is measured by methods such as microRNA chip, a next-generation sequencer and qPCR.
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	18 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	subjects whose serum is stored ,who consent to participate in this study
Key exclusion criteria	Not obtained the agreement
Target sample size	10

Research contact person
Name of lead principal investigator	Ken Ishii
Organization	National Institutes of Biomedical Innovation,Health and Nutrition
Division name	Laboratory of Adjuvant Innovation
Address	7-6-8 Asagi Saito Ibaraki-City Osaka
TEL	072-641-8043
Email	kenishii@biken.osaka-u.ac.jp

Public contact
Name of contact person	Ken Ishii
Organization	National Institutes of Biomedical Innovation,Health and Nutrition
Division name	Laboratory of Adjuvant Innovation
Address	7-6-8 Asagi Saito Ibaraki-City Osaka
TEL	072-641-8043
Homepage URL
Email	kenishii@biken.osaka-u.ac.jp

Sponsor
Institute	National Institutes of Biomedical Innovation,Health and Nutrition
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Axine Corporation(Australia)
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	2014 Year 01 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 21 Day
Anticipated trial start date	2012 Year 10 Month 01 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	About serum samples Serum samples are collected from subjects of clinical trial by Vaxine Corporation, and stored. Then samples and clinical information not containing personal information are only numbered and transported to National Institute of Biomedical Innovation.

Management information
Registered date	2014 Year 01 Month 27 Day
Last modified on	2016 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015127