Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Government body
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Clarke MF, Davidson GP, Gold MS, Marshall HS. Dire... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01472575