Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.

Inclusion Criteria:

• Healthy Japanese adults aged 20 to 60 years

Exclusion Criteria:

• History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
• Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
• Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
• History of progressive or severe neurological disorders