Last updated: 06/28/2019 09:40:11

Impact of rotavirus vaccination on hospitalisations for rotavirus gastroenteritis in children aged <5 years in Australia

GSK study ID
114910
See study documents
Clinicaltrials.gov ID
NCT01236066
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 study on the impact of rotavirus vaccination on hospitalisations for rotavirus gastroenteritis in children aged <5 years in Australia
Trial description: This study aims to monitor the incidence rates and duration of hospitalisations for rotavirus gastroenteritis (RV GE) and all cause GE, compared to bronchiolitis from 1998 to 2009, in children < 5 years of age after the introduction of Rotarix in 2006 by year, both inside and outside rotavirus season in Australia. It further aims to compare the two dose regimen of Rotarix with the three dose regimen of RotaTeq from 2007 to 2009.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of all cause gastroenteritis (GE) in children < 5 years by age group, state and year

Timeframe: Each year: 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009

Occurrence of rotavirus gastroenteritis (RV GE) in children < 5 years by age group, state and year

Timeframe: Each year: 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009

Occurrence of bronchiolitis in children < 5 years by age group, state and year

Timeframe: Each year: 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009

Mean age of full immunisation of Rotarix and RotaTeq in New South Wales and Queensland

Timeframe: From 2007 to 2009

Percentage of full immunisation of Rotarix and RotaTeq in New South Wales and Queensland according to age-specific recommendations for rotavirus (RV) immunisation in Australia

Timeframe: From 2007 to 2009

Percentage of full immunisation of Rotarix and RotaTeq in New South Wales and Queensland outside of age-specific recommendations for rotavirus (RV) immunisation in Australia

Timeframe: From 2007 to 2009

Percentage of children immunised with the last dose of Rotarix according to age-specific recommendations for rotavirus (RV) immunisation in Australia

Timeframe: From 2007 to 2009

Percentage of children immunised with the last dose of Rotarix outside of age-specific recommendations for rotavirus (RV) immunisation in Australia

Timeframe: From 2007 to 2009

Percentage of children immunised with the last dose of RotaTeq according to age-specific recommendations for rotavirus (RV) immunisation in Australia

Timeframe: From 2007 to 2009

Percentage of children immunised with the last dose of RotaTeq outside of age-specific recommendations for rotavirus (RV) immunisation in Australia

Timeframe: From 2007 to 2009

Secondary outcomes:
Not applicable
Interventions:
  • Other: Database analysis
    • Enrollment:
    1
    Primary completion date:
    2010-14-12
    Observational study model:
    Ecologic or Community
    Time perspective:
    Retrospective
    Clinical publications:
    Pendleton A et al. (2013) Impact of rotavirus vaccination in Australian children below 5 years of age: A database study. Hum Vaccin Immunother. 9(8):1617-1625.
    Medical condition
    Rotavirus gastroenteritis, Gastroenteritis
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    October 2010 to December 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable N/A - 5 years
    Accepts healthy volunteers
    No
    • Children <5 years of age;
    • Children with a diagnosis of all-cause gastroenteritis, rotavirus gastroenteritis or bronchiolitis in the Australian Institute of Health and Welfare (AIHW) database in New South Wales, Australian Capital Territory, Tasmania and Northern Territory, from 1998 to 2009;
    • No exclusion criteria will be applied.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Children <5 years of age;

      • Children with a diagnosis of all-cause gastroenteritis, rotavirus gastroenteritis or bronchiolitis in the Australian Institute of Health and Welfare (AIHW) database in New South Wales, Australian Capital Territory, Tasmania and Northern Territory, from 1998 to 2009;
      • Children who were vaccinated with Rotarix or RotaTeq in New South Wales and Queensland, registered in the Australian Childhood Immunisation Register (ACIR) database in Queensland and New South Wales, from 2007 to 2009.
    Exclusion criteria:
    • No exclusion criteria will be applied.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-14-12
    Actual study completion date
    2010-14-12

    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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    Access to clinical trial data by researchers
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