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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009259
Receipt No. 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

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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
Last 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
1st 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
Institute Department of Gastroenterology, Graduate School of Medicine, Osaka City University
Institute
Department

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
URL(English) https://upload.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


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