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Trial registered on ANZCTR


Registration number
ACTRN12611000559910
Ethics application status
Approved
Date submitted
31/05/2011
Date registered
1/06/2011
Date last updated
6/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of rotavirus vaccine introduction in SA
Scientific title
An observational, cross sectional, cohort study to assess the impact of rotavirus vaccine introduction on severe gastroenteritis in South Australian children.
Secondary ID [1] 262284 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe gastroenteritis 267986 0
Condition category
Condition code
Infection 268119 268119 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
introduction of rotavirus vaccine onto the National Immunisation Program in Australia. Rotavirus vaccine (Rotateq in SA) was introduced to be administered at 2,4 and 6 months of for infants born in Australia from 01May2011. This study is observational and examined the changes in severe rotavirus and severe gastroenteritis disease before and after the introduction of the vaccine. The study period is 01May2005 - 30April2011. Information regarding severe gastroneteritis was obtained from health information portal statistics and review of medical admission case notes for children born pre and post introduction of the rotavirus vaccine onto the National Immunisation Program.
Intervention code [1] 266676 0
Not applicable
Comparator / control treatment
cohort prior to introduction of the rotavirus vaccine onto the National Immunisation Program in Australia. Data is gathered from Health Information Portal statistics and review of medical admission case notes for the period 01May2005-30April2007.
Control group
Historical

Outcomes
Primary outcome [1] 266868 0
Prevalence of rotavirus coded hospital admissions
Timepoint [1] 266868 0
Period 01May2005-30Apr2007 (pre vaccine introduction) and 01May2009-30Apr2011 (post vaccine introduction)
Secondary outcome [1] 276530 0
Prevalence of all-cause gastroenteritis coded hospital admissions
Timepoint [1] 276530 0
Period 01May2005-30Apr2007 (pre vaccine introduction) and 01May2009-30Apr2011 (post vaccine introduction)
Secondary outcome [2] 276531 0
% severe (scored by severity index) of rotavirus coded hospital admissions
Timepoint [2] 276531 0
Period 01May2005-30Apr2007 (pre vaccine introduction) and 01May2009-30Apr2011 (post vaccine introduction)

Eligibility
Key inclusion criteria
aged 0-less than 6 years of age
admitted to hospital with ICD10-AM separation codes consistent with rotaviral infection or gastroenteritis of any cause.
Minimum age
0 Days
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nosocomial irotaviral nfections (defined as onset >48 hours post admission date) will be reported separately in the severity analysis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267168 0
Self funded/Unfunded
Name [1] 267168 0
Vaccinology and Immunology Research Trials Unit
Address [1] 267168 0
Discipline of Paediatrics,
Women's and Children's Hospital
Children, Youth and Women's Health Service
72 King William Road
North Adelaide SA 5006
Country [1] 267168 0
Australia
Primary sponsor type
Hospital
Name
Children, Youth and Women's health Service
Address
Children, Youth and Women's Health Service
72 King William Road
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 266243 0
None
Name [1] 266243 0
Address [1] 266243 0
Country [1] 266243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269157 0
Children, Youth and Women's Health Service Human Research Ethics Committee
Ethics committee address [1] 269157 0
Children, Youth and Women's Health Service
Human Research Ethics Committee
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 269157 0
Australia
Date submitted for ethics approval [1] 269157 0
08/04/2009
Approval date [1] 269157 0
01/05/2009
Ethics approval number [1] 269157 0
322A

Summary
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 gastrenteritis 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32681 0
Address 32681 0
Country 32681 0
Phone 32681 0
Fax 32681 0
Email 32681 0
Contact person for public queries
Name 15928 0
Dr Helen Marshall
Address 15928 0
Discipline of Paediatrics
Women's and Children's Hospital
72 King William Rd, North Adelaide, SA 5006
Country 15928 0
Australia
Phone 15928 0
+61 8 8161 8115
Fax 15928 0
Email 15928 0
helen.marshall@adelaide.edu.au
Contact person for scientific queries
Name 6856 0
Dr Helen Marshall
Address 6856 0
Discipline of Paediatrics
Women's and Children's Hospital
72 King William Rd, North Adelaide, SA 5006
Country 6856 0
Australia
Phone 6856 0
+61 8 8161 8115
Fax 6856 0
Email 6856 0
helen.marshall@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary