Last updated: 11/03/2018 16:16:00

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

GSK study ID
114131
Clinicaltrials.gov ID
NCT01202201
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Children <6 Years of Age in Japan
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

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

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

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

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

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

Secondary outcomes:

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

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

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

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

Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis

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

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

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

Seasonal distribution (monthly) of rotavirus gastroenteritis infection

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

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

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

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

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

Interventions:
  • Other: Database analysis
    • Enrollment:
    13767
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Nosocomial Rotavirus Gastroenteritis
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to February 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable N/A - 6 years
    Accepts healthy volunteers
    No
    • 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.
    • Participants of any kind of rotavirus vaccine clinical trial.
    Inclusion and exclusion criteria
    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:
    • Participants of any kind of rotavirus vaccine clinical trial.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-15-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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