Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects

This is an interventional prevention trial for Influenza focused on measuring influenza, vaccine, immunogenicity Read More

Inclusion Criteria:

• Males or non-pregnant females and aged ≥ 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 2010-2011 seasonal influenza vaccine 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, including the common cold or nasal congestion within 72 hours
• Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) 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 during the study
• Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent
• Immunodeficiency, or under immunosuppressive treatment
• Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
• 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