UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of vaccination subsidy program for seasonal influenza in schoolchildren by health insurer
Title of the study (Brief title)	Influenza Vaccination Program Effectiveness in Schoolchildren
Region	Japan

Condition
Condition	Influenza
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effectiveness of Flu vaccine in School children using health insurance vaccination program.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of influenza
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	1 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Children aged 1 to 15 years old covered by employee's health insurance providing vaccination subsidy.
Key exclusion criteria	None
Target sample size	20000

Research contact person
Name of lead principal investigator	Shinji Kosugi
Organization	Kyoto University
Division name	Department of Medical Ethics
Address	Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL	+81-75-753-4683
Email	urushihara.hisashi.2s@kyoto-u.ac.jp

Public contact
Name of contact person	Hisashi Urushihara
Organization	Keio University
Division name	Division of Drug Development & Regulatory Science, Faculty of Pharmacy
Address	1-5-30, Shiba-Koen, Minato-Ku, Tokyo, Japan
TEL	+81-3-5400-2649
Homepage URL
Email	urushihara-hs@pha.keio.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
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	2013 Year 10 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 29 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2014 Year 05 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1016/j.vaccine.2018.03.082
Results	Total study population throughout the four consecutive influenza seasons was over 116,000. Vaccination rate was higher in younger children and in the recent influenza seasons. Throughout the four seasons, the estimated ORs for influenza onset were statistically significant and ranged from 0.797 to 0.894 after doubly robust adjustment. On age stratification, significant ORs were observed in younger children. Additionally, ORs for influenza complication outcomes, such as pneumonia, hospitalization with influenza and respiratory tract diseases, were significantly reduced, except for hospitalization with influenza in the 2010/2011 and 2012/2013 seasons.
Other related information	Using claims database of employees' health insurer, the effectiveness of influenza vaccination subsidy program in schoolchildren is evaluated. Design: cohort study with more than 20 thousands schoolchildren enrolled in the health insurance. Observation period: Nov 2009 to Jul 2014 evaluation to be made for every single influenza season; 2010/2011, 2011/2012, 2012/2013, and 2013/2014. Exposure: Influenza vaccine subsidy Outcome: Influenza diagnosis

Management information
Registered date	2013 Year 10 Month 04 Day
Last modified on	2018 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=R000012894