Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12609000674235
Ethics application status
Approved
Date submitted
16/07/2009
Date registered
7/08/2009
Date last updated
7/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial of swine influenza vaccine in healthy adults
Scientific title
A randomised, controlled, study in healthy adults to evaluate the safety and immunogenicity of an adjuvanted recombinant 2009 H1N1 pandemic swine influenza vaccine
Secondary ID [1] 262904 0
FLU005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Swine influenza 237273 0
Condition category
Condition code
Infection 239595 239595 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recombinant 2009 H1 haemagglutinin in Advax-adjuvanted vaccine -Subjects will be randomised to receive one of three doses of haemagglutinin ranging from 5, 15 and 45 micrograms
Intervention code [1] 236955 0
Prevention
Comparator / control treatment
Recombinant 2009 H1 haemagglutinin 45 microgram dose without adjuvant will be the control treatment
Control group
Active

Outcomes
Primary outcome [1] 238385 0
Seroconversion to 2009 H1N1 as assessed by haemagglutination inhibition assay
Timepoint [1] 238385 0
3 weeks post first and second vaccination
Secondary outcome [1] 244847 0
Safety as assessed by frequency of vaccine-related and total adverse events
Timepoint [1] 244847 0
3 weeks post first and second vaccination
Secondary outcome [2] 257110 0
Anti-swine flu T-cell responses as assessed by T-cell recall responses
Timepoint [2] 257110 0
3 weeks post first and second vaccination
Secondary outcome [3] 257111 0
Vaccine tolerability as assessed by visual analogue pain score
Timepoint [3] 257111 0
At time of administration of first and second vaccination

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy
Lactation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237342 0
Hospital
Name [1] 237342 0
Flinders Medical Centre
Country [1] 237342 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 236831 0
None
Name [1] 236831 0
Address [1] 236831 0
Country [1] 236831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239460 0
Flinders Human Research Ethics Committee
Ethics committee address [1] 239460 0
Flinders medical Centre
Flinders Drive
Bedford Park
SA 5042
Ethics committee country [1] 239460 0
Australia
Date submitted for ethics approval [1] 239460 0
Approval date [1] 239460 0
Ethics approval number [1] 239460 0

Summary
Brief summary
This is the first human study of a novel swine flu vaccine that is designed to identify the optimum dose of vaccine, the optimum number of doses and whether or not an adjuvant is required to provide maximal protection against swine flu
Trial website
www.vaxine.com.au/swine_flu
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29912 0
Dr Dimitar Sajkov
Address 29912 0
Flinders Medical Centre
Flinders Drive
Bedford Park
Adelaide
Australia 5042
Country 29912 0
Australia
Phone 29912 0
+61882044572
Fax 29912 0
+61 8 82045987
Email 29912 0
dimitar.sajkov@health.sa.gov.au
Contact person for public queries
Name 13159 0
Nikolai Petrovsky
Address 13159 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 13159 0
Australia
Phone 13159 0
+61 8 82044572
Fax 13159 0
+61 8 82045987
Email 13159 0
nikolai.petrovsky@flinders.edu.au
Contact person for scientific queries
Name 4087 0
Nikolai Petrovsky
Address 4087 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Australia
Country 4087 0
Australia
Phone 4087 0
+61 8 82044572
Fax 4087 0
+61 8 82045987
Email 4087 0
nikolai.petrovsky@flinders.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AIRandomized clinical trial of immunogenicity and safety of a recombinant H1N1/2009 pandemic influenza vaccine containing Advax™ polysaccharide adjuvant2012https://doi.org/10.1016/j.vaccine.2012.06.009
N.B. These documents automatically identified may not have been verified by the study sponsor.