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
ACTRN12612000709842
Ethics application status
Approved
Date submitted
3/07/2012
Date registered
3/07/2012
Date last updated
14/01/2020
Date data sharing statement initially provided
14/01/2020
Date results information initially provided
14/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Seasonal influenza vaccine study to determine the effect of an adjuvanted 2012 influenza vaccine in adults
Scientific title
A randomised controlled trial to evaluate the immune response to an adjuvanted 2012 seasonal trivalent inactivated influenza vaccine in adults
Secondary ID [1] 280769 0
FLU006
Universal Trial Number (UTN)
Trial acronym
FLU006
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of influenza infection 286827 0
Condition category
Condition code
Infection 287136 287136 0 0
Other infectious diseases
Public Health 287137 287137 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single intramuscular immunization with standard 0.5ml dose of commercial 2012 seasonal influenza vaccine alone or combined with Advax(TM) adjuvant administered via either Stratis device or standard pre-filled syringe and needle
Intervention code [1] 285196 0
Prevention
Comparator / control treatment
Commercial 2012 seasonal influenza vaccine
Control group
Active

Outcomes
Primary outcome [1] 287452 0
Serum antibody titers
Timepoint [1] 287452 0
4 weeks post-immunization
Secondary outcome [1] 298179 0
B cell response as measured by frequency of memory B cells in the peripheral blood by flow cytometry and ELISPOT analysis
Timepoint [1] 298179 0
1 week post-immunization
Secondary outcome [2] 298180 0
T cell response as measured by frequency of memory and effector T cells in the peripheral blood by flow cytomerty and ELISPOT analysis
Timepoint [2] 298180 0
1,2,3 and 4 weeks post-immunization

Eligibility
Key inclusion criteria
Male or female
Age 18 years or over
Able to provide written informed consent
Willing and able to comply with the protocol for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of vaccination with the 2012 seasonal influenza vaccine
History of serious vaccine or egg allergy
Women of childbearing potential, unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, IUD or mechanical barrier device.
Pregnant or lactating women.
Receipt of another investigational agent within 14 days preceding initiation of treatment.
Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2012
Actual
31/03/2012
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
31/12/2014
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 285557 0
Commercial sector/Industry
Name [1] 285557 0
Vaxine Pty Ltd
Country [1] 285557 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042
Country
Australia
Secondary sponsor category [1] 284393 0
Charities/Societies/Foundations
Name [1] 284393 0
Australian Respiratory and Sleep Medicine Institute
Address [1] 284393 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042
Country [1] 284393 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287567 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 287567 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042
Ethics committee country [1] 287567 0
Australia
Date submitted for ethics approval [1] 287567 0
Approval date [1] 287567 0
23/03/2012
Ethics approval number [1] 287567 0
59.12

Summary
Brief summary
Trial of addition of adjuvant (immune enhancer) to improve effectiveness of seasonal influenza vaccine and trial of Stratis needleless injector device versus standard injection
Trial website
Trial related presentations / publications
Li L, Honda Y, Li C, Petrovsky N Delta inulin adjuvant enhances plasmablast generation, expression of activation-induced cytidine deaminase and B-cell affinity maturation in human subjects receiving seasonal influenza vaccine. PLOSOne, 2015 Jul 15;10(7):e0132003. doi: 10.1371/journal.pone.0132003. eCollection 2015.PMID 26177480

Petrovsky N, Yoshikazu Honda-Okubo Michael Royals, Kylie Bragg, Dimitar Sajkov. A randomized controlled pilot study to assess the immunogenicity and tolerability of a 2012 trivalent seasonal inactivated influenza vaccine administered via a disposable syringe jet injector device versus a traditional pre-filled syringe and needle. Trials in Vaccinology 2013, 2, 39-44. DOI: 10.1016/j.trivac.2013.09.002.
Public notes

Contacts
Principal investigator
Name 34387 0
Dr Dimitar Sajkov
Address 34387 0
Flinders Medical Centre
Flinders Drive
Bedford Park
Adelaide
Australia 5042
Country 34387 0
Australia
Phone 34387 0
+61 8 82044572
Fax 34387 0
+61 8 82045987
Email 34387 0
[email protected]
Contact person for public queries
Name 17634 0
Dr Dimitar Sajkov
Address 17634 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042
Country 17634 0
Australia
Phone 17634 0
+61 8 82044572
Fax 17634 0
Email 17634 0
[email protected]
Contact person for scientific queries
Name 8562 0
Prof Nikolai Petrovsky
Address 8562 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042
Country 8562 0
Australia
Phone 8562 0
+61 8 82044572
Fax 8562 0
Email 8562 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6413Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Petrovsky N, Yoshikazu Honda-Okubo Michael Royals,... [More Details] 362709-(Uploaded-30-12-2019-17-14-06)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA randomized controlled study to assess the immunogenicity and tolerability of a 2012 trivalent seasonal inactivated influenza vaccine administered via a disposable syringe jet injector device versus a traditional pre-filled syringe and needle2013https://doi.org/10.1016/j.trivac.2013.09.002
N.B. These documents automatically identified may not have been verified by the study sponsor.