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Sinovac Biotech Ltd., (Beijing, China), has announced positive results of a completed Phase 2 clinical trial of its pandemic influenza (H5N1) whole viron inactivated vaccine.
Sinovac Biotech Ltd., (Beijing, China), has announced positive results of a completed Phase 2 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 1b and 2 trials of the H5N1 whole viron vaccine and Phase 1 and Phase 2 trials of the H5N1 split vaccine.
The Phase 2 trial of the H5N1 whole viron inactivated vaccine was conducted by Beijing Centers for Disease Control and Prevention. The preliminary results of the trials suggested that each of the three dosages could induce varying degrees of immune response. The trial results did not show any serious adverse reactions among volunteers.
Sinovac has also recently completed the Phase 1 clinical trial of the split H5N1 vaccine. The result of vaccinations on children, adults, and the elderly with candidate vaccines of different dosages indicated that the split H5N1 vaccine is safe for human use.