UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009259
Receipt number R000010870
Scientific Title The investigations of efficacy and appropriate vaccination for trivalent influenza vaccine in patients with inflammatory bowel disease treated with immunomodulatory agents.
Date of disclosure of the study information 2012/11/05
Last modified on 2014/11/06 13:04:45

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Basic information

Public title

The investigations of efficacy and appropriate vaccination for trivalent influenza vaccine in patients with inflammatory bowel disease treated with immunomodulatory agents.

Acronym

Optimization of trivalent influenza vaccination in IBD patients treated with immunomodulatory agents.

Scientific Title

The investigations of efficacy and appropriate vaccination for trivalent influenza vaccine in patients with inflammatory bowel disease treated with immunomodulatory agents.

Scientific Title:Acronym

Optimization of trivalent influenza vaccination in IBD patients treated with immunomodulatory agents.

Region

Japan


Condition

Condition

inflammatory bowel disease

Classification by specialty

Medicine in general Gastroenterology Infectious disease
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Optimization of trivalent influenza vaccination in IBD patients treated with immunomodulatory agents.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The advantage for two dose of trivalent influenza vaccination compared to single dose vaccination in elder IBD patients or IBD patients treated with anti TNF-alpha agent or immunomodulator.

Key secondary outcomes

The comparison of the efficacy for trivalent influenza vaccination between IBD patients treated with immunomodulatory agents and healthy controls.


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

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

two dose of vaccination

Interventions/Control_2

single dose of vaccination

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


Not applicable

Age-upper limit

12 years-old >

Gender

Male and Female

Key inclusion criteria

IBD patients: Crohn's disease, Ulcerative colitis, Intestinal Bechet's disease
Healthy control:

Key exclusion criteria

1) Pediatric IBD patients less than 12 years old
2) Patients who were recognized as inadequacy by doctor
3) Patients who had past history of adverse event for vaccination

Target sample size

128


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Watanabe, M.D., Ph.D.

Organization

Graduate School of Medicine, Osaka City University

Division name

Department of Gastroenterology

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-3811

Email

kenjiw@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Watanabe, M.D., Ph.D.

Organization

Graduate School of Medicine, Osaka City University

Division name

Department of Gastroenterology

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-3811

Homepage URL


Email

kenjiw@med.osaka-cu.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Graduate School of Medicine, Osaka City University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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


Email



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 11 Month 05 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2012 Year 10 Month 19 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 05 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

2012 Year 11 Month 05 Day

Last modified on

2014 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010870


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name