Safety and Immunogenicity Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

Summary

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.

Timeline

Start

2006-06

Primary completion

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Completion

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Publications

• Ehrlich HJ, Muller M, Oh HM, Tambyah PA, Joukhadar C, Montomoli E, Fisher D, Berezuk G, Fritsch S, Low-Baselli A, Vartian N, Bobrovsky R, Pavlova BG, Pollabauer EM, Kistner O, Barrett PN; Baxter H5N1 Pandemic Influenza Vaccine Clinical Study Team. A clinical trial of a whole-virus H5N1 vaccine derived from cell culture. N Engl J Med. 2008 Jun 12;358(24):2573-84. doi: 10.1056/NEJMoa073121.

Drugs

Indications