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 | 2024/04/01 00:00:01 |
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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 | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
kenjiw1779@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
Homepage URL
kenjiw1779@gmail.com
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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka City University, Graduate School of Medicine
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
Tel
06-6645-3811
ethics@med.osaka-cu.ac.jp
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
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010870
