Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

Inclusion criteria

• Males and females 18 years of age and above on the day of enrollment;
• Individuals in good health
• Individuals are able to comply with all study procedures
• Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion criteria

• Individual not able to comprehend and to follow all required study procedures;
• History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
• Any serious chronic or progressive disease according to judgment of the investigator
• History of any anaphylaxis, serious vaccine reactions, to any excipients.
• Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
• Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
• Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
• Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
• Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
• Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
• History of progressive or severe neurological disorders;
• Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
• Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
• Female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
• Members of the research staff or their relatives.