Impact of Rotavirus Vaccine Introduction for South Australian Children

NCT ID: NCT01472575

Last Updated: 2011-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-12-31

Brief Summary

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

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.

Conditions

Viral Gastroenteritis Due to Rotavirus; Gastroenteritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility 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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Associate Professor Helen Marshall

OTHER_GOV

Sponsor Role: lead

Responsible Party

Associate Professor Helen Marshall

Director, Vaccinology and Immunology Research Trials Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Helen S Marshall, MBBS MD MPH

Role: PRINCIPAL_INVESTIGATOR

Women's and Children's Health Network

Locations

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Countries

Australia

References

Clarke MF, Davidson GP, Gold MS, Marshall HS. Direct and indirect impact on rotavirus positive and all-cause gastroenteritis hospitalisations in South Australian children following the introduction of rotavirus vaccination. Vaccine. 2011 Jun 24;29(29-30):4663-7. doi: 10.1016/j.vaccine.2011.04.109. Epub 2011 May 14.

Reference Type: RESULT

PMID: 21575665 (View on PubMed)

Other Identifiers

38070

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

38070

Identifier Type: -

Identifier Source: org_study_id