Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Non-Elderly Adult and Elderly Subjects

Inclusion Criteria:

• Males and non-pregnant females and aged ³ 18 years;
• Willing and able to adhere to visit schedules and all study requirements;
• Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

• Subject or his/her family is employed by the participated hospital;
• Subjects received influenza vaccine (Trivalent and/or A(H1N1)) within the previous 6 months;
• History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
• Personal or family history of Guillain-Barré Syndrome;
• An acute febrile illness within 1 week prior to vaccination;
• Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
• Patients with influenza-like illness as defined by the presence of fever (temperature ≥38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
• Female subjects who are pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
• Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
• Immunodeficiency, immunosuppressive or household contact with immunosuppression;
• History of wheezing or bronchodilator use within 3 months prior to study vaccine;
• Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt within 1 month of study vaccination;
• Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt within 1 month of study vaccination;
• Receipt of any blood products, including immunoglobulin in the prior 3 months;
• Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
• Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.