Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000350325
Ethics application status
Approved
Date submitted
19/06/2008
Date registered
23/07/2008
Date last updated
23/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antigen-sparing influenza vaccine study
Scientific title
A randomised, controlled Phase 1/2 study in healthy adults to evaluate the safety and immunogenicity of an inulin-adjuvanted antigen-sparing seasonal trivalent inactivated influenza vaccine
Secondary ID [1] 262903 0
FLU004
Universal Trial Number (UTN)
Trial acronym
FLU004
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 3287 0
Condition category
Condition code
Infection 3449 3449 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2008 seasonal trivalent inactivated influenza vaccine containing 15, 1.5 or 0.75 micrograms of haemagglutinin combined with polysaccharide adjuvant given once by intramuscular injection
Intervention code [1] 3024 0
Prevention
Comparator / control treatment
2008 seasonal trivalent inactivated influenza vaccine containing 45 micrograms of haemagglutinin and given once by intramuscular injection
Control group
Active

Outcomes
Primary outcome [1] 4343 0
Immunogenicity as assessed by haemagglutinin inhibition assay on subject serum sample
Timepoint [1] 4343 0
1 month
Primary outcome [2] 4344 0
Safety assessment as assessed by incidence of subject reported adverse events (AE) including prespecified local AE (pain, tenderness, swelling, bruising, redness) and systemic AE (fever/chills, joint pain, headache, muscle ache, fatigue, nausea/vomiting, diarrhoea) plus reported serious adverse events
Timepoint [2] 4344 0
1 month
Secondary outcome [1] 7317 0
Persistence of immune protection as assessed by haemagglutinin inhibition assay on subject serum sample
Timepoint [1] 7317 0
3 months

Eligibility
Key inclusion criteria
Healthy male or female
Non-pregnant
If child bearing age, using contraception (barrier method, intrauterine device or oral contraception)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of serious vaccine or egg allergy, 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 14 days preceding initiation of treatment, History of Guillain-Barre syndrome, 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
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
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3497 0
Self funded/Unfunded
Name [1] 3497 0
Country [1] 3497 0
Primary sponsor type
Commercial sector/Industry
Name
Vaxine pty Ltd
Address
Flinders Medical Centre
Adelaide 5042
Country
Australia
Secondary sponsor category [1] 3140 0
None
Name [1] 3140 0
Address [1] 3140 0
Country [1] 3140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5534 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 5534 0
Ethics committee country [1] 5534 0
Australia
Date submitted for ethics approval [1] 5534 0
Approval date [1] 5534 0
16/05/2008
Ethics approval number [1] 5534 0
75/08

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28681 0
Address 28681 0
Country 28681 0
Phone 28681 0
Fax 28681 0
Email 28681 0
Contact person for public queries
Name 11838 0
Professor David Gordon
Address 11838 0
Flinders Medical Centre
Adelaide 5042
Country 11838 0
Australia
Phone 11838 0
0882044572
Fax 11838 0
Email 11838 0
d.gordon@fmc.sa.gov.au
Contact person for scientific queries
Name 2766 0
Professor David Gordon
Address 2766 0
Flinders Medical Centre
Adelaide 5042
Country 2766 0
Australia
Phone 2766 0
0882044572
Fax 2766 0
Email 2766 0
d.gordon@fmc.sa.gov.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
No additional documents have been identified.