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
Vaxine Pty Ltd
200 participants
Mar 31, 2012
Interventional
Conditions
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
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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.
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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
Locations(1)
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ACTRN12612000709842