Enhanced Influenza Vaccines in Chronic Disease Study

Randomized, controlled Phase 1/2 study to evaluate the safety and effectiveness of an enhanced potency adjuvanted seasonal influenza vaccine in patients with chronic disease and the elderly

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000364370

Enrollment

1297

Registered

2008-07-25

Start date

2008-04-01

Completion date

2012-06-30

Last updated

2026-07-20

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

Conditions

None listed

Brief summary

This study seeks to determine whether the effectiveness of current flu vaccines in protecting people with chronic disease against flu-complications can be improved by addition of a specific compound (adjuvant) which acts by boosting the immune response to the vaccine

Interventions

Single dose of Advax-adjuvanted (20 miligram) seasonal 2008 trivalent inactivated influenza vaccination (total 45 micrograms of haemagglutinin) given once only by intramuscular injection

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

20 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

Diagnosis of chronic obstructive pulmonary disease, diabetes mellitus, cardiovascular disease or chronic renal disease or age 60 years or greater

Exclusion criteria

History of vaccination with current (2008) season influenza vaccine, History of vaccine or egg allergy, Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device, Pregnant or lactating women, Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids), Individuals with a known infection of human immunodeficiency virus (HIV), History of intravenous drug abuse or alcohol abuse

Outcome results