Clinical trial NCT01236066: Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia
Official title: A Study on the Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotavirus Gastroenteritis
Gastroenteritis
Keywords: Rotavirus Gastroenteritis
Rotarix
RotaTeq
Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-11-07
Enrollment: 1
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Australian children aged \< 5 years who have been vaccinated with RotaTeq (in Queensland) and Rotarix (in New South Wales) from 2007 to 2009 as well as all children aged \< 5 years hospitalised for all-cause gastroenteritis, rotavirus gastroenteritis or bronchiolitis, before and after introduction of Rotarix vaccination in New South Wales, Australian Capital Territory, Tasmania and Northern Territory, from 1998 to 2009.

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.


Eligibility 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.

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: Mean age of full immunisation of Rotarix and RotaTeq in New South Wales and Queensland
timeFrame: From 2007 to 2009
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pendleton A, Galic M, Clarke C, Ng SP, Ledesma E, Ramakrishnan G, Liu Y. Impact of rotavirus vaccination in Australian children below 5 years of age: a database study. Hum Vaccin Immunother. 2013 Aug;9(8):1617-25. doi: 10.4161/hv.24831. Epub 2013 Jun 3.