UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018975 |
|---|---|
| Receipt number | R000021722 |
| Scientific Title | A Study of Immunogenicity and Efficacy by quadrivalent Influenza Vaccination in Inflammatory Bowel Disease Patients |
| Date of disclosure of the study information | 2015/10/06 |
| Last modified on | 2018/03/13 10:20:29 |
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Basic information
Public title
A Study of Immunogenicity and Efficacy by quadrivalent Influenza Vaccination in Inflammatory Bowel Disease Patients
Acronym
Efficacy of Influenza Vaccination in Inflammatory Bowel Disease
Scientific Title
A Study of Immunogenicity and Efficacy by quadrivalent Influenza Vaccination in Inflammatory Bowel Disease Patients
Scientific Title:Acronym
Efficacy of Influenza Vaccination in Inflammatory Bowel Disease
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of immunogenicity and efficacy after one or two doses of quadrivalent influenza vaccine subcutaneously to Inflammatory Bowel Disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum antibody titers were measured prior to the first injection and after the first injection or the second injection (4~6 weeks starting with the first injection) and 4~6 weeks after the second dose and after influenza epidemic(HI antibody against influenza A and B)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Serum antibody titers obtained prior to vaccination and 4~6 weeks after the first and second dose of quadrivalent influenza vaccine were tested to Inflammatory bowel disease patients, and efficacy were reported.
Interventions/Control_2
Serum antibody titers obtained prior to vaccination and 4~6 weeks after the first and second dose of quadrivalent influenza vaccine were tested to healthy adults, and efficacy were reported.
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
| 15 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are able to follow the regulation of the trial and written informed consent can be obtained from patients or their legal guardian.
Key exclusion criteria
1) Pregnant patients.
2) patients with hypersensitivity to influenza vaccine.
8) Subjects judged as inadequate by the researchers.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Iwakiri |
Organization
Saga University Hospital
Division name
Internal medicine of Gastroenterology
Zip code
Address
5-1-1 Nabeshima Saga Japan
TEL
0952-31-6511
iwakiri@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinpei Shirai |
Organization
Saga University Hospital
Division name
Internal medicine of Gastroenterology
Zip code
Address
5-1-1 Nabeshima Saga Japan
TEL
0952-31-6511
Homepage URL
totoronin1029@gmail.com
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 10 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ibdjournal/advance-article-abstract/doi/10.1093/ibd/izx101/4925593
Number of participants that the trial has enrolled
Results
Single dose QIV showed sufficient immunogenicity in patients with inflammatory bowel disease, and a boost in immunization by additional vaccination was not obtained. Additionally, immunogenicity was low in patients receiving infliximab therapy.
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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 10 | Day |
Last modified on
| 2018 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021722
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
