Phase-3 Study of ASP7374, Cell-culture-derived Influenza Vaccine

Phase III Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Elderly Subjects

The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in elderly subjects.

Inclusion Criteria:

• Medically stable, as judged on the basis of history and concurrent diseases
• Subject understands procedure of the protocol and is willing to comply with the protocol

Exclusion Criteria:

• Scheduled to receive another vaccine during the study
• Received influenza HA vaccine within 180 days prior to screening
• Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine
• Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
• Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, human immunoglobulin products, blood products
• History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
• History of seizures
• History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
• Confirmed diagnosis of influenza within 84 days prior to screening test
• Body temperature of ≥37.5°C on Day 1 (before vaccination)
• Immunological tests reveal positive HBs antigen, HCV antibody, and HIV antigen and/or antibody