Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000161426
Ethics application status
Approved
Date submitted
7/02/2016
Date registered
10/02/2016
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A retrospective review of the pre-testing and vaccination using the Q VAX vaccine in Australian meat processor and livestock workers from 2002.
Scientific title
A retrospective analysis of the pre-testing results and immunisation rates of the Q VAX vaccine in Australian meat processor and livestock workers from 2002.
Secondary ID [1] 288303 0
CSLCT-QVX-15-11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Q Fever 297267 0
Condition category
Condition code
Infection 297466 297466 0 0
Other infectious diseases
Public Health 297772 297772 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prior to receiving the Q Fever vaccine, each person is required to undergo pre-testing. Pre-testing currently entails a skin and serology testing being performed to assess if they have been previously infected with Q Fever. This study is a retrospective analysis of the pre-testing performed prior to confirmation of the requirement for the Q fever vaccination (Q VAX).
The source of this data is the Australian Q Fever Registry, which is managed by AusVet. An individual is required to give their consent for data associated with the pre-testing and vaccination procedures to be entered into this Registry, and the Registry has been in operation since 2002. All data entered in the Registry from this date will be used in the retrospective analysis (2002 till approximately 31 Jan 2016).
Each individual is monitored by the clinic who administered the pre-testing and vaccination as required. There is no follow up period in this specific study.
Intervention code [1] 293601 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297031 0
To determine whether results from serology testing contribute additional information needed to confirm the decision to vaccinate with Q VAX. This will be done by a review of the individuals details, skin and serology test results contained in the Q Fever Registry.
Timepoint [1] 297031 0
Prior to vaccination with Q VAX
Secondary outcome [1] 319886 0
To assess the relationship between skin test results and serology results. This will be done by a review of the individuals details, skin and serology test results contained in the Q Fever Registry.
Timepoint [1] 319886 0
Prior to vaccination with Q VAX
Secondary outcome [2] 319887 0
To determine the percentage of participants in the Register who received vaccination with Q VAX. This will be done by a review of the individuals details, skin and serology test results contained in the Q Fever Registry.
Timepoint [2] 319887 0
At the time of Q VAX vaccination

Eligibility
Key inclusion criteria
Completion of Q Fever Register Consent form
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The Full Analysis Set (FAS) will include all individuals enrolled into the registry and entered into the electronic registry by the date of data transfer. The FAS will be used for all data summaries and analyses. All available data will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/02/2016
Actual
8/03/2016
Date of last participant enrolment
Anticipated
Actual
25/04/2016
Date of last data collection
Anticipated
Actual
25/04/2016
Sample size
Target
138000
Accrual to date
Final
138040
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 292678 0
Commercial sector/Industry
Name [1] 292678 0
Seqirus Pty Ltd
Country [1] 292678 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Seqirus Pty Ltd
Address
Seqirus Pty Ltd, a company of CSL
63 Poplar Road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 291398 0
None
Name [1] 291398 0
NA
Address [1] 291398 0
NA
Country [1] 291398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294147 0
Bellberry HREC
Ethics committee address [1] 294147 0
129 Glen Osmond Road
Eastwood, SA 5063
Ethics committee country [1] 294147 0
Australia
Date submitted for ethics approval [1] 294147 0
13/01/2016
Approval date [1] 294147 0
08/03/2016
Ethics approval number [1] 294147 0

Summary
Brief summary
The aim of the study is to perform a retrospective analysis of the Q Fever Register’s data to determine the profile of individuals included in the Register, and determine the rate of vaccination and whether results from serology testing contribute additional information to support the decision to vaccinate.
Trial website
Trial related presentations / publications
Public notes
The study has been completed

Contacts
Principal investigator
Name 62698 0
Dr Daphne Sawlwin
Address 62698 0
Seqirus Pty Ltd, a company of CSL
63 Poplar Road
Parkville, VIC 3052
Country 62698 0
Australia
Phone 62698 0
+61 3 9389 2000
Fax 62698 0
Email 62698 0
[email protected]
Contact person for public queries
Name 62699 0
Ms Carolyn Stone
Address 62699 0
Strategy Red Solutions - a consulting group working for Seqirus Pty Ltd
PO Box 1171
South Melbourne VIC 3205
Country 62699 0
Australia
Phone 62699 0
+61432523564
Fax 62699 0
Email 62699 0
[email protected]
Contact person for scientific queries
Name 62700 0
Ms Carolyn Stone
Address 62700 0
Strategy Red Solutions - a consulting group working for Seqirus Pty Ltd
PO Box 1171
South Melbourne VIC 3205
Country 62700 0
Australia
Phone 62700 0
+61432523564
Fax 62700 0
Email 62700 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.