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

Phase 1

Completed

• Conditions: Infection - Other infectious diseases; Prevention of influenza infection; Public Health - Other public health

• Registration Number: ACTRN12612000709842
• Lead Sponsor: Vaxine Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-03
• Study Completion: 2014-12-31
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum antibody titers[4 weeks post-immunization]

Secondary Outcome Measures

Name	Time	Method
B cell response as measured by frequency of memory B cells in the peripheral blood by flow cytometry and ELISPOT analysis[1 week post-immunization];T cell response as measured by frequency of memory and effector T cells in the peripheral blood by flow cytomerty and ELISPOT analysis[1,2,3 and 4 weeks post-immunization]