Impact of Rotavirus Vaccine Introduction for South Australian Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Women's and Children's Hospital, Australia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Associate Professor Helen Marshall, Women's and Children's Hospital, Australia
ClinicalTrials.gov Identifier:
NCT01472575
First received: November 9, 2011
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

This project aims to assess the impact of rotavirus vaccine introduction on severe gastroenteritis in South Australian children. Prevalence of rotavirus coded hospitalisations and all-cause gastroenteritis hospitalisations will be compared for a two year period prior to introduction of the vaccine and a two year period following introduction of the vaccine. Severity of rotavirus coded admissions during the periods will also be assessed.

Hypotheses:

  1. Introduction of the rotavirus vaccine will result in an 80% reduction in hospitalisations for rotavirus positive gastroenteritis (ICD code A0.80) in children less than two years of age.
  2. Introduction of rotavirus vaccine will result in an 80% reduction in Paediatric Emergency presentations for rotavirus positive gastroenteritis in children under two years of age.
  3. Introduction of the rotavirus vaccine will result in a 50% reduction in hospitalisations for all cause gastroenteritis (ICD codes A0.00-A0.90) in children less than two years of age.
  4. Introduction of the rotavirus vaccine will result in a 50% reduction in Paediatric Emergency presentations for all cause gastroenteritis in children less than two years of age.
  5. Introduction of rotavirus vaccine will result in a reduction in hospitalisation and Paediatric Emergency presentations in children aged four and five years with rotavirus positive gastroenteritis (unvaccinated cohort).
  6. There will be no difference in severity of disease as scored by the Vesikari and/or clark severity score prior to and post introduction of rotavirus vaccine

Condition
Viral Gastroenteritis Due to Rotavirus
Gastroenteritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Observational, Cross-sectional, Cohort Study to Assess the Impact of the Rotavirus Vaccine Introduction on Severe Gastroenteritis in South Australian Children

Resource links provided by NLM:


Further study details as provided by Women's and Children's Hospital, Australia:

Primary Outcome Measures:
  • Change in prevalence of rotavirus coded hospital admissions before and after introduction of rotavirus vaccination [ Time Frame: 2 years prior to vaccine introduction (01May2005-30Apr2007) and 2 years post vaccine introduction (01May2009-30Apr2011) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in prevalence of all-cause gastroenteritis coded hospital admissions before and after rotavirus vaccination introduction [ Time Frame: 2 years prior to vaccine introduction (01May2005-30Apr2007) and 2 years post vaccine introduction (01May2009-30Apr2011) ] [ Designated as safety issue: No ]
  • Change in proportion of admissions scored as severe (scored by severity index) for rotavirus coded hospital admissions before and after introduction of rotavirus vaccination [ Time Frame: 2 years prior to vaccine introduction (01May2005-30Apr2007) and 2 years post vaccine introduction (01May2009-30Apr2011) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pre- rotavirus vaccination introduction
Children aged 0-less than 6 years of age admitted to hospital in South Australia with ICD10-AM separation codes consistent with rotaviral infection or gastroenteritis of any cause during the period 01May2005-30Apr2007 (pre vaccine introduction)
post rotavirus vaccine introduction
Children aged 0-less than 6 years of age admitted to hospital in South Australia with ICD10-AM separation codes consistent with rotaviral infection or gastroenteritis of any cause during the period 01May2009-30Apr2011 (post vaccine introduction)

Detailed Description:

This project aims to assess vaccine effectiveness in the field following introduction of the rotavirus vaccine in South Australian children. It is important to confirm the benefits of the vaccine post licensure to ensure the best health care options for children. Between July 2007 - June 2008 at the Women's and Children's Hospital, there were approximately 2000 gastroenteritis patient samples analysed, with approximately 200 of these confirmed as rotavirus positive (10%). The current vaccines available in Australia (Rotarix® and RotaTeq® ) are licensed for administration in infants up to six months of age as safety data is not yet available for older children. It is therefore important to determine whether vaccination according to the current Australian Standard Vaccination Schedule can also demonstrate a positive change (less disease and less severe disease) in the burden of rotavirus disease in older unvaccinated children.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

males and females aged 0-less than 6 years of age admitted to SA hospital with ICD10-AM separation codes consistent with rotaviral infection or gastroenteritis of any cause.

- for severity component, admissions to the Women's and Children's Hospital will be examined.

Criteria

Inclusion Criteria:

  • males and females aged 0-less than 6 years of age admitted to SA hospital with ICD10-AM separation codes consistent with rotaviral infection or gastroenteritis of any cause.
  • for severity component, only admissions to the Women's and Children's Hospital will be examined

Exclusion Criteria:

  • nosocomial rotaviral infections (defined as onset >48 hours post admission date) will be reported separately in the severity analysis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01472575

Locations
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Sponsors and Collaborators
Associate Professor Helen Marshall
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Helen S Marshall, MBBS MD MPH Women's and Children's Health Network
  More Information

Publications:
Responsible Party: Associate Professor Helen Marshall, Director, Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital, Australia
ClinicalTrials.gov Identifier: NCT01472575     History of Changes
Other Study ID Numbers: 38070, 38070
Study First Received: November 9, 2011
Last Updated: November 15, 2011
Health Authority: Australia: National Health and Medical Research Council
Australia: Human Research Ethics Committee

Keywords provided by Women's and Children's Hospital, Australia:
rotavirus
gastroenteritis
vaccination
hospitalisation

Additional relevant MeSH terms:
Gastroenteritis
Enteritis
Adenovirus Infections, Human
Enterovirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adenoviridae Infections
DNA Virus Infections
Virus Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on July 22, 2014