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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotavirus Gastroenteritis, Gastroenteritis

Intervention / Treatment
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* Other: Database analysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>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. | Other: Database analysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Mean age of full immunisation of Rotarix and RotaTeq in New South Wales and Queensland |  | 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 |  | 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 according to 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 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 outside of age-specific recommendations for rotavirus (RV) immunisation in Australia |  | From 2007 to 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotavirus Gastroenteritis, Rotarix, RotaTeq, Gastroenteritis