A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted with MF59 (FLUAD-H5N1), in Adult and Elderly Subjects

Woman and Man

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Extract

Safety Objectives • To assess the safety and tolerability profile of two doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (FLUAD-H5N1), each containing 7.5 µg of H5N1 antigen. • To contribute to an integrated safety database of approximately 3300 subjects exposed to FLUAD-H5N1, capable of detecting rare adverse events in adult subjects, i.e. events that occur at a frequency of <=0.1%, and uncommon adverse events in elderly, i.e. that occur at a frequency of <=1%. Immunogenicity Objectives • To evaluate the immunogenicity of two doses of FLUAD-H5N1, each containing 7.5 µg of H5N1 antigen, versus the homologous A/Vietnam/1194/2004 strain. • To evaluate the immunogenicity of two doses of FLUAD-H5N1, each containing 7.5 µg of H5N1 antigen, versus the heterovariant A/turkey/Turkey/1/2005 strain.

Inclusion criteria

Pandemic influenza

Kusajili – Clinical trials directory

A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted with MF5...