BEIJING, Dec. 24 /Xinhua-PRNewswire/ -- Sinovac Biotech Ltd. (Amex: SVA), a leading provider of vaccines in China, today announced 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 H5N1 whole viron inactivated vaccine was conducted by Beijing Centers for Disease Control and Prevention. It included 402 volunteers, between the ages of 18 and 60, who were each vaccinated with two doses of 5 ug, 10 ug or 15 ug. The preliminary results of the trials suggested that each of the three dosages can induce varying degrees of immune response. In particular, the anti-HI seroconversion rate, the increasing GMT and protection rate of the H5N1 whole viron inactivated vaccines for the 10ug and 15ug dosages reached the EMEA evaluation standards of seasonal flu vaccines, which is an indication of good immunogenicity of the vaccine. The trial result did not show any serious adverse reaction among volunteers, suggesting the vaccine's good safety profile.
In addition, Sinovac recently completed the phase I clinical trial of the split H5N1 vaccine. The result of vaccinations on children, adults and elderly with candidate vaccines of different dosage indicated that the split H5N1 vaccine is safe for human use.
Mr. Weidong Yin, Chairman, President and CEO, stated, "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.
|SOURCE Sinovac Biotech Ltd.|
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