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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033033
Receipt No. R000037661
Scientific Title Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <10 years in Japan: an ecological assessment
Date of disclosure of the study information 2018/07/01
Last modified on 2019/08/20

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Basic information
Public title Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <10 years in Japan: an ecological assessment
Acronym Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <10 years in Japan: an ecological assessment
Scientific Title Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <10 years in Japan: an ecological assessment
Scientific Title:Acronym Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <10 years in Japan: an ecological assessment
Region
Japan

Condition
Condition Rotavirus gastroenteritis
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate and describe the trend of the incidence of severe rotavirus gastroenteritis during rotavirus season in children aged <10 years in Japan before and after the introduction of rotavirus vaccines during the era that these vaccines have not been introduced in national immunization program.
Basic objectives2 Others
Basic objectives -Others Discuss about population impact of rotavirus vaccines.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Inpatient hospitalization due to rotavirus gastroenteritis
Key secondary outcomes Inpatient hospitalization due to acute gastroenteritis

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

Not applicable
Age-upper limit
10 years-old >
Gender Male and Female
Key inclusion criteria All children aged <10 years between 01 Jan 2009 and 31 Dec 2017 will be identified in Japan Medical Data Center Co. Ltd., database.
Key exclusion criteria No exclusion criteria in this study.
Target sample size 156000

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Kobayashi
Organization MSD K.K.
Division name Medical Affairs
Zip code 102-8667
Address 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL 03-6272-2049
Email ldgproject@merck.com

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Kobayashi
Organization MSD K.K.
Division name Medical Affairs
Zip code 102-8667
Address 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL 03-6272-2049
Homepage URL
Email ldgproject@merck.com

Sponsor
Institute MSD K.K.
Institute
Department

Funding Source
Organization MSD K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Institute of Healthcare Data Sciene
Address Sumitomoshibadaimon building 12F, Shibadaimon 2-5-5, Minato-ku. Tokyo
Tel 03-5733-5010
Email rihds@jmdc.co.jp

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
2018 Year 07 Month 01 Day

Related information
URL releasing protocol https://www.tandfonline.com/doi/full/10.1080/21645515.2019.1638204
Publication of results Published

Result
URL related to results and publications https://www.tandfonline.com/doi/full/10.1080/21645515.2019.1638204
Number of participants that the trial has enrolled 0
Results
In children aged under 5 years, the incidence of RVGE hospitalizations greatly declined in 2014 after vaccine introduction, consistent with our previous findings, and the decline was sustained until 2017. However, in children aged 5 to 9 years, no apparent trend for a continuous decline in RVGE hospitalizations was observed during the study period. 
Results date posted
2019 Year 08 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All children who were <10 years of age during the study period (1st January 2009 to 31st December 2017)  in the database constructed by JMDC Inc. were included in the analysis. 
Participant flow
Not applicable because of retrospective study using database.
Adverse events
Not applicable because of retrospective study using database.
Outcome measures
The primary outcome parameter was hospitalization due to Rotavirus gastroeneritis according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 04 Month 05 Day
Date of IRB
2018 Year 05 Month 23 Day
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a database-studty using database constructed by Japan Medical Data Center Co. Ltd., (JMDC; Tokyo, Japan).

Management information
Registered date
2018 Year 06 Month 18 Day
Last modified on
2019 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037661

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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