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Clinical Trials associated with Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)(Ology Bioservices)An Open-Label Phase I/II Study to Assess the Safety and Immunogenicity of Two Doses of a Vero Cell Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Volunteers Aged 21 to 45 Years
The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review the safety data after the first and second vaccination.
An Open Label Phase III Study of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine to Assess the Immunogenicity and Safety and to Investigate the Need for and Timing of a Booster Vaccination
The objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study will assess the need for a booster vaccination and whether a 6-month booster or a 12-month booster is more appropriate. An independent data safety monitoring board will review and evaluate the safety data obtained in this study on an ongoing basis.
A Phase I/II Dose Escalation Study of a Vero Cell-Derived, Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 45 Years
The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.
100 Clinical Results associated with Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)(Ology Bioservices)
100 Translational Medicine associated with Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)(Ology Bioservices)
100 Patents (Medical) associated with Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)(Ology Bioservices)
100 Deals associated with Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)(Ology Bioservices)