UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011957 |
|---|---|
| Receipt number | R000012894 |
| Scientific Title | Effectiveness of vaccination subsidy program for seasonal influenza in schoolchildren by health insurer |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2018/11/06 14:41:05 |
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Basic information
Public title
Effectiveness of vaccination subsidy program for seasonal influenza in schoolchildren by health insurer
Acronym
Influenza Vaccination Program Effectiveness in Schoolchildren
Scientific Title
Effectiveness of vaccination subsidy program for seasonal influenza in schoolchildren by health insurer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shinji Kosugi |
Organization
Kyoto University
Division name
Department of Medical Ethics
Zip code
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL
+81-75-753-4683
urushihara.hisashi.2s@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Urushihara |
Organization
Keio University
Division name
Division of Drug Development & Regulatory Science, Faculty of Pharmacy
Zip code
Address
1-5-30, Shiba-Koen, Minato-Ku, Tokyo, Japan
TEL
+81-3-5400-2649
Homepage URL
urushihara-hs@pha.keio.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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)
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
| 2013 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.vaccine.2018.03.082
Number of participants that the trial has enrolled
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.
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
| 2013 | Year | 07 | Month | 29 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012894
