Antigen-sparing influenza vaccine study

A randomised, controlled Phase 1/2 study in healthy adults to evaluate the safety and immunogenicity of an inulin-adjuvanted antigen-sparing seasonal trivalent inactivated influenza vaccine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000350325

Acronym

FLU004

Enrollment

250

Registered

2008-07-23

Start date

2008-07-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Study in healthy adult subjects of an antigen-sparing influenza vaccine strategy incorporating an immune enhancing polysaccharide in the normal influenza vaccine

Interventions

2008 seasonal trivalent inactivated influenza vaccine containing 15, 1.5 or 0.75 micrograms of haemagglutinin combined with polysaccharide adjuvant given once by intramuscular injection

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy male or female Non-pregnant If child bearing age, using contraception (barrier method, intrauterine device or oral contraception)

Exclusion criteria

History of serious vaccine or egg allergy, Pregnant or lactating women, Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids), Participation in another clinical trial with an investigational agent within 14 days preceding initiation of treatment, History of Guillain-Barre syndrome, 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