Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose
 schedule in immunologically naïve adults against one vaccine formulation without adjuvant in
 terms of tolerance and immunogenicity

 Primary Objective:

 To describe the safety profile and immunogenicity following each injection.
Inclusion Criteria :

 -  Aged 18 to 40 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.

 Exclusion Criteria :

 -  Participation in another clinical trial in the 4 weeks preceding the first trial
 vaccination.

 -  Planned participation in another clinical trial during the present trial period.

 -  Previous participation in a clinical trial involving an investigational flu pandemic
 vaccine.

 -  Vaccination with an influenza vaccine during the past 6 months

 -  Any vaccination in the 4 weeks preceding the first trial vaccination

 -  Vaccination planned in the 4 weeks following any trial vaccination

 -  Breast-feeding.

 -  For a woman of child-bearing potential, the absence of an effective method of
 contraception or abstinence non observed for at least 4 weeks prior to the first
 vaccination and at least 4 weeks after the last vaccination.

 -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer
 chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic
 corticosteroid therapy.

 -  Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C
 seropositivity.

 -  Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the
 vaccine components, or history of a life-threatening reaction to the trial vaccine or
 a vaccine containing the same substances.

 -  Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.

 -  Chronic illness at a stage that could interfere with trial conduct or completion.

 -  Current abuse of alcohol or drug addiction that may interfere with the subject's
 ability to comply with trial procedures.

 -  Subject deprived of freedom by an administrative or court order, or in an emergency
 setting, or hospitalized without his/her consent.

 -  Blood or blood-derived products received in the past 3 months.

 -  Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.

 -  Laboratory abnormalities considered clinically significant upon the Investigator's
 judgment in blood sample taken at screening (for Step 1 only)