UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of Immunogenicity and Efficacy by quadrivalent Influenza Vaccination in Inflammatory Bowel Disease Patients
Title of the study (Brief title)	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	Ryuichi Iwakiri
Organization	Saga University Hospital
Division name	Internal medicine of Gastroenterology
Address	5-1-1 Nabeshima Saga Japan
TEL	0952-31-6511
Email	iwakiri@cc.saga-u.ac.jp

Public contact
Name of contact person	Shinpei Shirai
Organization	Saga University Hospital
Division name	Internal medicine of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://academic.oup.com/ibdjournal/advance-article-abstract/doi/10.1093/ibd/izx101/4925593
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.
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/icdr_e/ctr_view.cgi?recptno=R000021722