Seasonal influenza vaccine study to determine the effect of an adjuvanted 2012 influenza vaccine in adults

A randomised controlled trial to evaluate the immune response to an adjuvanted 2012 seasonal trivalent inactivated influenza vaccine in adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000709842

Acronym

FLU006

Enrollment

200

Registered

2012-07-03

Start date

2012-03-31

Completion date

2012-12-31

Last updated

2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

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.

Outcome results