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

Completed

• Conditions: Gastroenteritis; Rotavirus Gastroenteritis
• Interventions: Other: Database analysis

• Registration Number: NCT01236066
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Database analysis	Australian children aged \< 5 years who have been vaccinated with RotaTeq or Rotarix from 2007 to 2009 as well as all children aged \< 5 years hospitalised for all-cause gastroenteritis, rotavirus gastroenteritis or bronchiolitis.

Primary Outcome Measures

Name	Time	Method
Occurrence of all cause gastroenteritis (GE) in children < 5 years by age group, state and year	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	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	From 2007 to 2009
Occurrence of bronchiolitis in children < 5 years by age group, state and year	Each year: 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 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	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	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	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	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	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	From 2007 to 2009