Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults

Inclusion criteria

• Healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator.
• Males and females aged 20-40 years.
• Provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures.

Exclusion criteria

• Body Mass Index (BMI) 30 kg/m2 and above.
• Has a history of a A/H5N1 influenza virus infection and subjects had received other A/H5N1 influenza vaccine.
• Has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0C) within 2 days of vaccination.
• Has a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM).
• Has severe allergic diseases.
• Has asthma.
• Has a history of convulsions.
• Has a history of any serious disease.
• Known impairment of imune function.
• Known rheumatism and autoimmune disease.
• Receipt of medicines that would affect evaluation of immunogenicity.
• Receipt of any live virus vaccination or receipt of any inactivated vaccine/toxoid prior to enrollment.
• Blood donation prior to enrollment.
• Receipt of another investigation agent prior to enrollment.
• History of alcohol or drug abuse.
• Females who are pregnant or potentially childbearing or are breastfeeding.
• Ineligible subject based on the judgement of the investigator.