ANZCTR - Registration

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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 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]

FLU006

Universal Trial Number (UTN)

Trial acronym

FLU006

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prevention of influenza infection

Condition category

Condition code

Infection

Other infectious diseases

Public Health

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]

Prevention

Comparator / control treatment

Commercial 2012 seasonal influenza vaccine

Control group

Active

Outcomes

Primary outcome [1]

Serum antibody titers

Timepoint [1]

4 weeks post-immunization

Secondary outcome [1]

B cell response as measured by frequency of memory B cells in the peripheral blood by flow cytometry and ELISPOT analysis

Timepoint [1]

1 week post-immunization

Secondary outcome [2]

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]

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)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vaxine Pty Ltd

Address [1]

Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042

Country [1]

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]

Charities/Societies/Foundations

Name [1]

Australian Respiratory and Sleep Medicine Institute

Address [1]

Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide 
South Australia
5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/03/2012

Ethics approval number [1]

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

Dr Dimitar Sajkov

Address

Flinders Medical Centre
Flinders Drive
Bedford Park
Adelaide
Australia 5042

Country

Australia

Phone

+61 8 82044572

Fax

+61 8 82045987

[email protected]

Contact person for public queries

Name

Dimitar Sajkov

Address

Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042

Country

Australia

Phone

+61 8 82044572

Fax

[email protected]

Contact person for scientific queries

Name

Nikolai Petrovsky

Address

Flinders Medical Centre
1 Flinders Drive
Bedford Park
Adelaide
South Australia
5042

Country

Australia

Phone

+61 8 82044572

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6413	Study protocol			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	A 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 needle	2013	https://doi.org/10.1016/j.trivac.2013.09.002

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically