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CompletedNCT01202201Updated Jun 7, 2017

A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan

An observational study in Nosocomial Rotavirus Gastroenteritis and Rotavirus Gastroenteritis, sponsored by GlaxoSmithKline. Completed. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2017-06-07.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
13,767
Ages
Up to 6 Years
Sex
All
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Study summary

The purpose of this study is to evaluate the epidemiology and baseline disease burden of rotavirus gastroenteritis in children \< 6 years of age, in Japan.

Read the detailed description

This is a retrospective database study wherein data on children who have been diagnosed with acute gastroenteritis or rotavirus gastroenteritis will be collected from the electronic admission database or any other applicable database of the participating hospitals.

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Conditions studied

  • Nosocomial Rotavirus Gastroenteritis
  • Rotavirus Gastroenteritis

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In context

Gastroenteritis

243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.

This study's enrollment of 13,767 is above the median of 611 across 71 observational studies indexed under Gastroenteritis.

Browse Gastroenteritis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children \<6 years of age hospitalized with acute gastroenteritis or rotavirus gastroenteritis in any of the participating hospitals

Inclusion criteria

  • A male or female child aged \<6 years at the time of admission in hospital. A child will become ineligible on the day of her/his sixth birthday.
  • A subject who is hospitalized with any acute gastroenteritis or rotavirus gastroenteritis during the survey period.

Exclusion criteria

Exclusion Criteria:

  • Participants of any kind of rotavirus vaccine clinical trial.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
13,767 participants (actual)

Groups and cohorts

  • Study Cohort

    Subjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis

    Other: Database analysis

Interventions

  • OtherDatabase analysis

    Review and collect data from database (electronic admission database or any other applicable database of the hospital)

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What researchers measure

Primary outcomes

  1. Occurrence of acute gastroenteritis among all hospitalized children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  2. Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  3. Occurrence of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

Secondary outcomes

  1. Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  2. Occurrence of nosocomial rotavirus gastroenteritis among all hospitalizations with rotavirus gastroenteritis in children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  3. Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  4. Occurrence of rotavirus gastroenteritis hospitalization and nosocomial rotavirus gastroenteritis hospitalization among children <6 years of age, stratified by age

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  5. Seasonal distribution (monthly) of rotavirus gastroenteritis infection

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  6. Age (monthly) specific data of all the outcome measures, for children <12 months of age

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  7. Number of hospitalizations with rotavirus gastroenteritis and other vaccine-preventable infectious diseases such as influenza, mumps and varicella among children <6 years of age

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Tajiri H, Takeuchi Y, Takano T, Ohura T, Inui A, Yamamoto K, Higashidate Y, Kawashima H, Toyoda S, Ushijima K, Ramakrishnan G, Rosenlund M, Holl K. The burden of rotavirus gastroenteritis and hospital-acquired rotavirus gastroenteritis among children aged less than 6 years in Japan: a retrospective, multicenter epidemiological survey. BMC Pediatr. 2013 May 22;13:83. doi: 10.1186/1471-2431-13-83. PubMed 23697664 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01202201
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 15, 2010
Start date
Sep 2010
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Jun 7, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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