UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024647 |
|---|---|
| Receipt number | R000028357 |
| Scientific Title | Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <5 years in Japan: an ecological assessment |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2018/01/10 16:48:33 |
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Basic information
Public title
Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <5 years in Japan: an ecological assessment
Acronym
Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <5 years in Japan: an ecological assessment
Scientific Title
Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <5 years in Japan: an ecological assessment
Scientific Title:Acronym
Incidence of severe rotavirus gastroenteritis pre and post vaccine introduction in children aged <5 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 <5 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
| 0 | years-old | <= |
Age-upper limit
| 5 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All children aged <5years between 01 Jan 2009 and 31 Dec 2015 will be identified in Japan Medical Data Center Co. Ltd., database.
Key exclusion criteria
No exclusion criteria in this study.
Target sample size
780000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kobayashi |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-2049
ldgproject@merck.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Kobayashi |
Organization
MSD K.K.
Division name
Medical Affairs
Zip code
Address
1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-2049
Homepage URL
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
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
| 2016 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29241644
Number of participants that the trial has enrolled
Results
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
Main results already published
Date of protocol fixation
| 2016 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
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
| 2016 | Year | 10 | Month | 31 | Day |
Last modified on
| 2018 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028357
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
