UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033033
Receipt number 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 17:25:47

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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 or person

Institute

MSD K.K.

Institute

Department

Personal name



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

Value
https://center6.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