Sinovac Biotech Ltd. announced in a statement positive top-line results of completed Phase II clinical trial of its pandemic influenza (H5N1) whole viron inactivated vaccine. The stratified, randomized, double-blind trial of the vaccine was designed to assess the safety and immunogenicity of the vaccine.
Sinovac received approval from the China State Food and Drug Administration (SFDA) in April 2007 to conduct Phase Ib and II trials of the H5N1 whole viron vaccine and phase I and phase II trials of the H5N1 split vaccine.
The Phase II trial of the pandemic influenza (H5N1) whole viron inactivated vaccine included 402 volunteers, between the ages of 18 and 60, who were each vaccinated with two doses of 5ug, 10ug or 15ug. The preliminary results of the trials suggested that each of the three dosages can induce varying degrees of immune response. The trial result did not show any serious adverse reaction among volunteers, suggesting the vaccine's good safety profile.
Weidong Yin, chairman, president and CEO, said: "We are very pleased with the achievements of our team that led to the development of a pandemic influenza vaccine. After Phase II clinical trials of the whole viron H5N1 vaccine, the vaccine dosages and schedule can now be determined. This accomplishment is a further step towards providing an effective prevention option for the government in the event of a future influenza pandemic."