A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of FLUAD-H5N1 (Surface Antigen Adjuvanted with MF59C.1) Influenza Vaccine in Non-elderly Adult and Elderly Subjects

Femme et Homme

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Extrait

1. To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of FLUAD-H5N1 influenza vaccine containing either 7.5ﾵg or 15ﾵg of H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test. 2. To evaluate the safety of the administration of one 0.5mL IM booster dose of FLUADH5N1 influenza vaccine containing 7.5ﾵg of H5N1 influenza antigen 17-18 months after primary immunization.

Critère d'inclusion

Active immunoprofilaxis against potential pandemic influenza strain

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A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of FLUAD-H5N1 (Surface Antigen Adjuvanted with MF59C.1) Influenza Vaccine in Non-elderly Adult and ...