A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2009-2010, when Administered to Non-elderly Adult and Elderly Subjects

Woman and Man

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Extract

To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes. (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. CPMP/BWP/214/96: 12 March 1997)

Inclusion criteria

The virus strains responsible for influenza vary in an unpredictable fashion, therefore the type of virus as well as the magnitude of influenza activity changes from one winter to the other. Therefore its necessary continuous monitoring of the influenza epidemic by national surveillance systems. Following the recommendations of these surveillance systems, anti-influenza vaccines are produced ad hoc every year and distributed worldwide according to the new variants of the influenza virus

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A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2009-2010, when Administered ...