Sinovac Begins Phase II Clinical Trail on H5N1 Vaccine
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[ Industry Watch ] CHINA Sinovac Begins Phase II Clinical Trial on H5N1 Vaccine inovac Biotech Ltd, a leading China-based biopharmaceutical company focusing on human vaccine development, has announced that it has Scommenced vaccination of volunteers for its Phase II clinical research study of its pandemic influenza H5N1 vaccine. The Phase II clinical trial is a randomized double-blind study to assess the safety and efficacy of the pandemic influenza H5N1 vaccine. The trial started with 400 adult volunteers vaccinated with pandemic influenza whole viron H5N1 Vaccine. The initial result from this study is expected to be available by the end of 2007. Phase II clinical trial for the H5N1 vaccine was approved in April 2007 by the China State Food and Drug Administration (SFDA). The SFDA approval covers Phase Ib and II trials of the whole viron vaccine and Phase I and II trials of the split vaccine. Phase Ib clinical trial with whole viron H5N1 vaccine and Phase I clinical trial with split H5N1 vaccine commenced in August 2007. The company is reported to be making good progress on these trials. About Sinovac Sinovac Biotech Ltd is a China-based biopharmaceutical company that Contact Details: focuses on the research, development, manufacture and commercialization Sinovac Biotech Ltd of vaccines that protect against human infectious diseases. Sinovac’s vaccines Address: 39 Shangdi Xi Road, Haidian District, include HealiveTM (hepatitis A), BiliveTM (combined hepatitis A and B) Beijing 100085 TM and Anflu (influenza). Sinovac is currently developing human vaccines Tel: +86 108 289 0088 against the H5N1 strain of pandemic influenza, Japanese encephalitis and Fax: +86 106 296 6910 SARS. ■ URL: www.sinovac.com www.asiabiotech.com Volume 11 > Number 19 > 2007 ■ 1281.