UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Japanese prospective multi-center study of the effectiveness and safety of influenza vaccine.
Title of the study (Brief title)	FLU STUDY'14-'15/JPA(I)
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the effectiveness and the safety of influenza vaccine.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of influenza illness Adverse event of vaccination
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	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

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Not applicable
Key exclusion criteria	Not applicable
Target sample size

Research contact person
Name of lead principal investigator	Norio Iwaki
Organization	Japan Physicians Association
Division name	Influenza study group
Address	1-2-2 Hitotsubashi Chiyoda-ku, Tokyo-to, Japan
TEL	03-5224-6110
Email	jpa@oregano.ocn.ne.jp

Public contact
Name of contact person	Naoki Kawai
Organization	Japan Physicians Association
Division name	Influenza study group
Address	1-2-2 Hitotsubashi Chiyoda-ku, Tokyo-to, Japan
TEL	03-5224-6110
Homepage URL
Email	jpa@oregano.ocn.ne.jp

Sponsor
Institute	Influenza study group, Japan Physicians Association
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	None
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 10 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 29 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2015 Year 05 Month 31 Day
Date of closure to data entry	2015 Year 05 Month 31 Day
Date trial data considered complete	2015 Year 06 Month 30 Day
Date analysis concluded	2015 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.japha.jp
Results	The efficacy and the safety of the influenza vaccine.
Other related information	Register influenza vaccine recipients group and the non-vaccinated group. Compare a number of affected individuals with vaccine recipients and non-vaccinated.

Management information
Registered date	2014 Year 10 Month 17 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017971