A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine

▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay

• Proportion of subjects, stratified by group, with seroconversion to HI antibody
• Proportion of subjects, stratified by group, achieving a serum hemagglutination inhibition assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus
• GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer

• Safety Outcome Measures :

• Solicited adverse events(Day 0 ~ 6, Day 21 ~ 27) 2. Unsolicited adverse events(Day 0 ~ 42) 3. Adverse events(Day 21 ~ 6 months)

Inclusion criteria

• Healthy adults age 18 and older.
• Are able to understand and comply with planned study procedures.
• Provide written informed consent prior to initiation of any study procedures.

Exclusion criteria

• Have a known allergy to eggs, chickens or other components of the vaccine(including MF59).
• Have immunosuppression including immunodeficiency disease.
• Have a history of Guillain-Barre Syndrome.
• Have a diagnosis of thrombocytopenia.
• Have a chronic disease that the investigator believes may interfere with successful completion of the study. (Excluding regulating hypertension)
• Hemophilia Patients or Are receiving anti-coagulating agents. Low-dose aspirin (100mg/day) purpose of prevention is allowed.
• Are receiving anti-viral agents.
• Have an acute fever, a temperature greater than 38℃(100.4 degrees Fahrenheit) within 72 hours of vaccination or Have a symptom of acute febrile illness within 14 days prior to vaccination in this study.
• Received below agents or expect to receive agents within following periods. A. Have immunosuppression therapy, radiotherapy, use of high-dose glucocorticoids or prednisolone(≥15mg/day) within 6 months prior to vaccination in this study.Inhaled, nasal and topical steroids are allowed) B. Have a history of receiving immunoglobulin or other blood product within 3 months prior to vaccination in this study.

C. Received an experimental agent within 1 month prior to vaccination in this study.

D. Received any vaccines(live licensed and inactivated licensed) within 1 month prior to vaccination in this study. (Excluding seasonal Influenza vaccine)

• Those who are not eligible to receive vaccine injection in the arm deltoid muscle.
• Pregnant females, Nursing mom, Those women who have a chance to become pregnant, but not taking a proper contraception.
• Not agree to abstain from drinking following 7 days of vaccination.
• Have any condition (clinically regardful medical or psychological condition) that would, in the opinion of the site investigator, render them unable to meet the requirements of the protocol.