Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

This study is a randomized, double-blinded, Phase 2 study to assess the safety and
immunogenicity of 2 doses of long-term stored inactivated monovalent influenza
A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in
healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is
designed to assist in stockpile management and will assess the usability of long-term stored
H5N1 antigen (ie, stored >10 years) and adjuvant (ie, stored >5 years).

Inclusion Criteria:

- Male or nonpregnant female

- Provide written informed consent prior to study-related procedures

- Stable health status

- Access to consistent and reliable means of telephone contact

- Able to understand and comply with planned study procedures

- Agree to stay in contact with site, and no plans to move from study area for study
duration

Exclusion Criteria:

- Allergic to eggs, other vaccine components, or squalene-based adjuvants

- Women with positive pregnancy test within 24 hours of vaccination, or are
breastfeeding

- Females of childbearing potential who refuse acceptable birth control, if sexually
active, have not used birth control for 2 months prior to study entry

- Have immunosuppression or use anticancer chemotherapy or radiation therapy within
preceding 36 months

- Have an active neoplastic disease or history of hematologic malignancy

- Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or
high-dose inhaled steroids (>800 mcg/day) within preceding 6 months

- Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis

- Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to
self or others within past 10 years