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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Rotavirus Gastroenteritis; Gastroenteritis

Treatments: Other: Database analysis

Study type: Observational

Funder types: Industry

Identifiers

NCT01236066

114910

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 1 patient group

Study Group

Description:

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.

Treatment:

Other: Database analysis