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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01472575




Registration number
NCT01472575
Ethics application status
Date submitted
9/11/2011
Date registered
16/11/2011
Date last updated
16/11/2011

Titles & IDs
Public title
Impact of Rotavirus Vaccine Introduction for South Australian Children
Scientific title
An Observational, Cross-sectional, Cohort Study to Assess the Impact of the Rotavirus Vaccine Introduction on Severe Gastroenteritis in South Australian Children
Secondary ID [1] 0 0
38070
Secondary ID [2] 0 0
38070
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Viral Gastroenteritis Due to Rotavirus 0 0
Gastroenteritis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in prevalence of rotavirus coded hospital admissions before and after introduction of rotavirus vaccination
Timepoint [1] 0 0
2 years prior to vaccine introduction (01May2005-30Apr2007) and 2 years post vaccine introduction (01May2009-30Apr2011)
Secondary outcome [1] 0 0
Change in prevalence of all-cause gastroenteritis coded hospital admissions before and after rotavirus vaccination introduction
Timepoint [1] 0 0
2 years prior to vaccine introduction (01May2005-30Apr2007) and 2 years post vaccine introduction (01May2009-30Apr2011)
Secondary outcome [2] 0 0
Change in proportion of admissions scored as severe (scored by severity index) for rotavirus coded hospital admissions before and after introduction of rotavirus vaccination
Timepoint [2] 0 0
2 years prior to vaccine introduction (01May2005-30Apr2007) and 2 years post vaccine introduction (01May2009-30Apr2011)

Eligibility
Key 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
Minimum age
No limit
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- nosocomial rotaviral infections (defined as onset >48 hours post admission date) will
be reported separately in the severity analysis

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2011
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Associate Professor Helen Marshall
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01472575
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helen S Marshall, MBBS MD MPH
Address 0 0
Women's and Children's Health Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01472575