Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000172606
Ethics application status
Approved
Date submitted
4/02/2014
Date registered
12/02/2014
Date last updated
13/10/2021
Date data sharing statement initially provided
13/10/2021
Date results information initially provided
13/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Identification of the determinants of under-vaccination of infants and children in Western Australia
Scientific title
What are the determinants of under vaccination rates of infants and children in Western Australia
Secondary ID [1] 284028 0
CVID/2013-03
Universal Trial Number (UTN)
Trial acronym
Under-vaccination study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccination 291077 0
Condition category
Condition code
Infection 291420 291420 0 0
Other infectious diseases
Public Health 291478 291478 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Parents of children under six will be asked to complete a questionnaire about their attitudes towards childhood vaccination. Only one questionnaire will be required (on the day of consent). Parents will be asked for their consent to check details of vaccination records with their child's primary healthcare provider and details of the child's inpatient medical history.
Intervention code [1] 288719 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291408 0
Determinants of vaccination will be assessed by the use of a parent questionnaire and review of the child's medical record at the time of questionnaire completion
Timepoint [1] 291408 0
Questionnaire will be completed on one occasion only - at the time of consent
Secondary outcome [1] 306702 0
Nil
Timepoint [1] 306702 0
N/A

Eligibility
Key inclusion criteria
Parents / Guardians of children under 6 years of age giving informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previously enrolled

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
19/08/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
28/05/2015
Date of last data collection
Anticipated
Actual
31/12/2015
Sample size
Target
1000
Accrual to date
Final
601
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2048 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 7737 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 288656 0
Self funded/Unfunded
Name [1] 288656 0
Country [1] 288656 0
Primary sponsor type
Other Collaborative groups
Name
Telethon Institute for Child Health Research
Address
100 Roberts Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 287367 0
None
Name [1] 287367 0
Address [1] 287367 0
Country [1] 287367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290508 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 290508 0
Roberts Road
Subiaco WA 6008
Ethics committee country [1] 290508 0
Australia
Date submitted for ethics approval [1] 290508 0
01/10/2013
Approval date [1] 290508 0
02/04/2014
Ethics approval number [1] 290508 0

Summary
Brief summary
The purpose of the study is to identify the key determinants of under-vaccination among infants and children in Western Australia (WA).
This study will compare socio-demographic characteristics of parents of under-vaccinated compared with fully-vaccinated children, and stated beliefs/attitudes held by parents towards vaccination and toward vaccine preventable diseases. In addition, we will survey parents about perceived barriers to vaccination and potential solutions to improve confidence in or accessibility to vaccination.
Through the identification of determinants of direct relevance to WA families, we expect to inform effective strategies to improve vaccine coverage in WA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46010 0
Dr Tom Snelling
Address 46010 0
Telethon Institute for Child Health Research
100 Roberts Road
Subiaco WA 6009
Country 46010 0
Australia
Phone 46010 0
+61 8 9489 7777
Fax 46010 0
Email 46010 0
[email protected]
Contact person for public queries
Name 46011 0
Dr Claire Waddington
Address 46011 0
Telethon Institute for Child Health Research
100 Roberts Road
Subiaco WA 6009
Country 46011 0
Australia
Phone 46011 0
+61 8 9489 7777
Fax 46011 0
Email 46011 0
[email protected]
Contact person for scientific queries
Name 46012 0
Dr Claire Waddington
Address 46012 0
Telethon Institute for Child Health Research
100 Roberts Road
Subiaco WA 6009
Country 46012 0
Australia
Phone 46012 0
+61 8 9489 7777
Fax 46012 0
Email 46012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes April 2019 Vaccine X 1:100010 DOI:10.1016/j.jvacx... [More Details] 365738-(Uploaded-30-04-2021-09-36-45)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.