Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000599471
Ethics application status
Approved
Date submitted
14/11/2007
Date registered
21/11/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study in healthy Australian adult subjects comparing the standard commercial flu vaccine with an enhanced flu vaccine containing a natural plant-derived immune enhancer
Scientific title
A randomised, controlled Phase 1/2 study in healthy adults of a seasonal influenza vaccine containing an inulin-based adjuvant to evaluate safety and immunogenicity
Secondary ID [1] 262906 0
FLU001
Universal Trial Number (UTN)
Trial acronym
FLU001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal influenza prevention 2205 0
Condition category
Condition code
Respiratory 2300 2300 0 0
Other respiratory disorders / diseases
Public Health 2655 2655 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of intramuscular administration of reduced dose seasonal trivalent inactivated influenza vaccine (15micrograms) containing Advax adjuvant (20mg) versus standard dose intramuscular seasonal trivalent inactivated influenza vaccine (45 micrograms)
Intervention code [1] 1920 0
Prevention
Comparator / control treatment
Commercial trivalent inactivated seasonal influenza vaccine (45 micrograms) administered by intramuscular injection into deltoid muscle
Control group
Active

Outcomes
Primary outcome [1] 3191 0
Incidence of adverse events
Timepoint [1] 3191 0
21 days from immunisation
Primary outcome [2] 3192 0
Seroconversion and seroprotection against influenza measured according to Therapeutic Goods Administration (TGA) criteria as contained in Harmonisation of Requirements for Influenza Vaccines, Directive 75/318/EEC as amended
Timepoint [2] 3192 0
21 days post immunisation
Secondary outcome [1] 5322 0
Kinetics of immunological responses to influenza vaccine (antibody and T cell responses)
Timepoint [1] 5322 0
T cell responses to influenza haemaggutinin as measured 21 days post-immunisation

Eligibility
Key inclusion criteria
• Non-pregnant
• If child bearing age, using contraception (barrier method, intrauterine device (IUD) or oral contraception)
• 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
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Known immunodeficiency (including human immunodeficiency virus (HIV)
• diabetes mellitus
• History of vaccine or egg allergy
• Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device (IUD) or mechanical barrier device.
• Pregnant or lactating women.
• Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids).
• Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment.
• History of intravenous drug abuse or alcohol abuse

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)
Blinded envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator (www.randomization.com)
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 324 0
5042

Funding & Sponsors
Funding source category [1] 2799 0
Commercial sector/Industry
Name [1] 2799 0
Vaxine Pty Ltd
Country [1] 2799 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Flinders Medical Centre
Adelaide SA 5042
Country
Australia
Secondary sponsor category [1] 2238 0
None
Name [1] 2238 0
Address [1] 2238 0
Country [1] 2238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4717 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 4717 0
Flinders Medical Centre
Adelaide SA 5042
Ethics committee country [1] 4717 0
Australia
Date submitted for ethics approval [1] 4717 0
Approval date [1] 4717 0
Ethics approval number [1] 4717 0

Summary
Brief summary
A major challenge in influenza vaccines is to find a way to deliver considerably lower doses of influenza vaccine while still being able to elicit a protective immune response. This is because the number of doses of seasonal influenza vaccine able to be generated is limited by production capacity and cost.Extensive animal data indicates addition of a natural plant sugar called Advax results in enhanced immunity and/or reduced antigen requirements compared to current unadjuvanted human influenza vaccines. This study will test the safety and effectiveness of a low dose flu vaccine containing Advax to the standard full dose commercial flu vaccine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27734 0
Address 27734 0
Country 27734 0
Phone 27734 0
Fax 27734 0
Email 27734 0
Contact person for public queries
Name 11109 0
Nikolai Petrovsky
Address 11109 0
Flinders Medical Centre
Adelaide SA 5042
Country 11109 0
Australia
Phone 11109 0
+61 8 82044572
Fax 11109 0
+61 8 82045987
Email 11109 0
nikolai.petrovsky@flinders.edu.au
Contact person for scientific queries
Name 2037 0
Nikolai Petrovsky
Address 2037 0
Flinders Medical Centre
Adelaide SA 5042
Country 2037 0
Australia
Phone 2037 0
+61 8 82044572
Fax 2037 0
+61 8 82045987
Email 2037 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
EmbaseHuman Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with AdvaxTM delta inulin adjuvant.2016https://dx.doi.org/10.1016/j.vaccine.2016.05.071
N.B. These documents automatically identified may not have been verified by the study sponsor.