Trial of swine influenza vaccine in healthy adults

A randomised, controlled, study in healthy adults to evaluate the safety and immunogenicity of an adjuvanted recombinant 2009 H1N1 pandemic swine influenza vaccine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000674235

Enrollment

300

Registered

2009-08-07

Start date

2009-07-20

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

This is the first human study of a novel swine flu vaccine that is designed to identify the optimum dose of vaccine, the optimum number of doses and whether or not an adjuvant is required to provide maximal protection against swine flu

Interventions

Recombinant 2009 H1 haemagglutinin in Advax-adjuvanted vaccine -Subjects will be randomised to receive one of three doses of haemagglutinin ranging from 5, 15 and 45 micrograms

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 adults

Exclusion criteria

Pregnancy Lactation

Outcome results