Last updated: 06/28/2019 09:40:11
Impact of rotavirus vaccination on hospitalisations for rotavirus gastroenteritis in children aged <5 years in Australia
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Ecologic or Community
Primary completion date:
2010-14-12
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 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.
Children <5 years of age;
Exclusion criteria:
- No exclusion criteria will be applied.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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