Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

Inclusion criteria

• Aged 18 to 60 years on day of inclusion.
• Informed Consent Form signed.
• Able to attend all scheduled visits and to comply with all trial procedures.
• For a woman, inability to bear a child or negative urine pregnancy test.
• For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.

Exclusion criteria

• Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
• Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
• Breast-feeding.
• Previous vaccination with an avian flu vaccine.
• Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
• Planned participation in another clinical trial during the present trial period.
• Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
• Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
• Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures.
• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
• Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.