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Impact of Rotavirus Vaccine Introduction for South Australian Children

NCT01472575 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2011-11-16

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

Principal Investigators

  • Helen S Marshall, MBBS MD MPH · Women's and Children's Health Network

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472575 on ClinicalTrials.gov