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

NCT01236066 | Completed

• 1 other identifier: 114910
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotavirus Gastroenteritis; Gastroenteritis

Keywords

Rotavirus Gastroenteritis; Rotarix; RotaTeq; Gastroenteritis

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Study Group

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

Interventions

Database analysis OTHER

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.

Study Group

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 23733041 DERIVED

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 8, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 7, 2017

Record last verified: 2017-06