Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects

This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.

Inclusion criteria

• Healthy adults aged 19 years or older.
• The subjects who give written consent to participate in the study voluntarily and are able to comply with all study requirements.
• If female and capable of bearing children,subject has a negative urine pregnancy test result on screening and agrees to employ adequate birth control measures through the study period.

Exclusion criteria

• Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
• Subjects with immune deficiency disorder.
• History of Guillain-Barre syndrome.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• Subjects who experienced fever within 24 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day or with any acute respiratory infection.
• Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
• Subjects who had received blood products or immunoglobulin within 3 months before screening.
• Subjects who had received influenza vaccination within 6 months prior to the screening.
• Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination.
• Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
• Subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination.
• Subjects with clinically significant chronic disease or malignant cancer.
• Pregnant women, breast-feeding women.
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.