Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)

Exclusion Criteria

• •Subjects who have any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC):
• •pregnancy
• •chronic disorders of the pulmonary or cardiovascular system including asthma (hypertension is not considered a high risk condition)
• •chronic renal disorders
• •chronic hepatic disorders
• •chronic hematological disorders
• •chronic metabolic disorder (including diabetes mellitus)
• •immunosuppression (including immunosuppression caused by medications or HIV)
• •any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders or other neuromuscular disorders)
• •residence in a nursing home or other chronic care facility that houses persons of any age who have chronic medical conditions
• •household contact with children aged 0 to 59 months or of someone who is included in the risk categories listed above
• •employment as a health care worker
• •Subjects are also excluded if they
• •are unable to lead an independent life as a result of either physical or mental handicap
• •have a history of severe allergic reactions or anaphylaxis
• •have a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating
• •have received a blood transfusion or immunoglobulins within 90 days of study entry
• •have received a live vaccine within 4 weeks or inactivated vaccine within 2 weeks of study entry
• •have previously been vaccinated against influenza for the 2007/2008 northern hemisphere influenza season
• •have functional or surgical asplenia
• •have a known or suspected problem with alcohol or drug abuse
• •were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
• •are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, spouse/partner, siblings, parents) as well as employees of the investigator.