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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018975
Receipt No. 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

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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
Email 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
Email totoronin1029@gmail.com

Sponsor
Institute Saga University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021722

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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