A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults (FLU003)
Influenza
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- Ambulatory males or females aged 18 years and over
- Able to provide written informed consent
- Willing and able to comply with the protocol for the duration of the study.
- Not planning to have seasonal influenza vaccine within 2 months from the time of the first trial immunization
Exclusion Criteria:
- Pregnant or lactating women.
- Women of childbearing potential unless using a reliable and appropriate contraceptive method.
- Receipt of another investigational agent within 28 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.
Sites / Locations
- Flinders University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
HA 45ug
HA 45ug+Advax1
HA 45ug+Advax2
HA 15ug+Advax1
HA 15ug+Advax2
HA 5ug+Advax1
HA 5ug+Advax2
HA 2.5ug+Advax2
HA 15ug
recombinant influenza hemagglutinin (H5) 45ug, i.m. injection, 2 doses
recombinant influenza hemagglutinin(H5) 45ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
recombinant influenza hemagglutinin (H5) 45ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
recombinant influenza hemagglutinin (H5) 15ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
recombinant influenza hemagglutinin (H5) 15ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
recombinant influenza hemagglutinin (H5) 5ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
recombinant influenza hemagglutinin (H5) 5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
recombinant influenza hemagglutinin (H5) 2.5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
recombinant influenza hemagglutinin (H5) 15ug, i.m. injection, 2 doses