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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhanced Influenza Vaccines in Chronic Disease Study
Scientific title
Randomized, controlled Phase 1/2 study to evaluate the safety and effectiveness of an enhanced potency adjuvanted seasonal influenza vaccine in patients with chronic disease and the elderly
Secondary ID [1] 591 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 3278 0
Chronic Obstructive Pulmonary Disease 3279 0
Diabetes Mellitus 3280 0
Chronic renal disease 3281 0
Old age 3282 0
Condition category
Condition code
Cardiovascular 3443 3443 0 0
Diseases of the vasculature and circulation including the lymphatic system
Respiratory 3444 3444 0 0
Public Health 3445 3445 0 0
Other public health

Study type
Description of intervention(s) / exposure
Single dose of Advax-adjuvanted (20 miligram) seasonal 2008 trivalent inactivated influenza vaccination (total 45 micrograms of haemagglutinin) given once only by intramuscular injection
Intervention code [1] 3019 0
Intervention code [2] 3020 0
Treatment: Other
Comparator / control treatment
Single dose of seasonal 2008 trivalent inactivated influenza vaccination (total 45 micrograms of haemagglutinin) given once only by intramuscular injection
Control group

Primary outcome [1] 4336 0
Immunogenicity as assessed by haemagglutination inhibition assay (HAI)
Timepoint [1] 4336 0
3-4 weeks post vaccination
Primary outcome [2] 4337 0
Safety as assessed by local (e.g. injection site reactions including pain, swelling, erythema) and systemic adverse events (e.g. fever, nausea, myalgia) as recorded in subject diaries and routine biochemical and haematological screening assays
Timepoint [2] 4337 0
3 weeks post vaccination
Secondary outcome [1] 7309 0
Influenza-related morbidity as assessed by incidence of respiratory infections, hospitalisations and unscheduled general practitioner or emergency department visits need for antibiotic therapy.
Timepoint [1] 7309 0
3, 6, and 12 months post vaccination

Key inclusion criteria
Diagnosis of chronic obstructive pulmonary disease, diabetes mellitus, cardiovascular disease or chronic renal disease or age 60 years or greater
Minimum age
20 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
History of vaccination with current (2008) season influenza vaccine, History of vaccine or egg allergy, Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device, Pregnant or lactating women, Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids), Individuals with a known infection of human immunodeficiency virus (HIV), History of intravenous drug abuse or alcohol abuse

Study design
Purpose of the study
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
Other design features
Phase 1 / Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3493 0
Commercial sector/Industry
Name [1] 3493 0
Vaxine Pty Ltd
Address [1] 3493 0
Flinders Medical Centre
Adelaide 5042
Country [1] 3493 0
Primary sponsor type
Commercial sector/Industry
Vaxine pty Ltd
Flinders Medical Centre
Adelaide 5042
Secondary sponsor category [1] 3136 0
Name [1] 3136 0
Address [1] 3136 0
Country [1] 3136 0

Ethics approval
Ethics application status
Ethics committee name [1] 5530 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 5530 0
Flinders Medical Centre
Adelaide 5042
Ethics committee country [1] 5530 0
Date submitted for ethics approval [1] 5530 0
Approval date [1] 5530 0
Ethics approval number [1] 5530 0

Brief summary
This study seeks to determine whether the effectiveness of current flu vaccines in protecting people with chronic disease against flu-complications can be improved by addition of a specific compound (adjuvant) which acts by boosting the immune response to the vaccine
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 28677 0
Address 28677 0
Country 28677 0
Phone 28677 0
Fax 28677 0
Email 28677 0
Contact person for public queries
Name 11834 0
Dr Dimitar Sajkov
Address 11834 0
Flinders Medical Centre
Adelaide 5042
Country 11834 0
Phone 11834 0
Fax 11834 0
Email 11834 0
Contact person for scientific queries
Name 2762 0
Professor Nikolai Petrovsky
Address 2762 0
Flinders Medical Centre
Adelaide 5042
Country 2762 0
Phone 2762 0
Fax 2762 0
Email 2762 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary