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A Phase II, Open Label, Uncontrolled, Multi-Center Study to support annual strain update and to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, (Adjuvanted with MF59C.1) Infl...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000964-26

A Phase II, Open Label, Uncontrolled, Multi-Center Study to support annual strain update and to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, (Adjuvanted with MF59C.1) Influenza Vaccine, Formulation 2007-2008, when Administered to Subjects aged 18-64 years affected by chronic diseases

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Extrait

Immunogenicity Objectives To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-vaccination in at risk adult subjects in compliance with the requirements of the current EU recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). Safety Objectives To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD in at risk adult subjects.

Critère d'inclusion

  • The Flu vaccine is used for active prophilaxisys for the influenza, in subjects with chronic diseases (Hypertension, cardiopatie, BOCD, asthma,renal or hepatic insufficiency, arteriosclerosis and diabetes insulindependent)

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