Skip to content

Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia

A Study on the Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01236066
Enrollment
1
Registered
2010-11-08
Start date
2010-10-31
Completion date
2010-12-31
Last updated
2017-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis, Rotavirus Gastroenteritis

Keywords

Rotavirus Gastroenteritis, Rotarix, RotaTeq, Gastroenteritis

Brief summary

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.

Interventions

Existing computerised administrative databases from the Australian Institute of Health and Welfare (AIHW) will be reviewed to retrieve data on all-cause gastroenteritis/ rotavirus enteritis and bronchiolitis hospitalisations of children \<5 years in all the states using Rotarix from 1998 to 2009. Data from Australian Childhood Immunisation Register (ACIR) post introduction of rotavirus vaccines in the National Immunisation Program (2007 to 2009) will also be used.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Occurrence of all cause gastroenteritis (GE) in children < 5 years by age group, state and yearEach 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 yearEach 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 yearEach 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 QueenslandFrom 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 AustraliaFrom 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 AustraliaFrom 2007 to 2009
Percentage of children immunised with the last dose of Rotarix according to age-specific recommendations for rotavirus (RV) immunisation in AustraliaFrom 2007 to 2009
Percentage of children immunised with the last dose of Rotarix outside of age-specific recommendations for rotavirus (RV) immunisation in AustraliaFrom 2007 to 2009
Percentage of children immunised with the last dose of RotaTeq according to age-specific recommendations for rotavirus (RV) immunisation in AustraliaFrom 2007 to 2009
Percentage of children immunised with the last dose of RotaTeq outside of age-specific recommendations for rotavirus (RV) immunisation in AustraliaFrom 2007 to 2009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026