Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

Inclusion Criteria:

• Healthy adults aged >18 years

Exclusion Criteria:

• serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
• history of any anaphylaxis, serious vaccine reactions
• hypersensitivity against vaccine components
• history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
• known or suspected impairment/alteration of immune function
• more than one injection of influenza vaccine received or laboratory confirmed influenza disease
• within last 6 months: influenza vaccination received