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news.Sinovac Biotech has initiated volunteer enrollment in its Phase II clinical trial for its split pandemic influenza vaccine. The preliminary results from this study are expected to be available in early 2009.
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The randomized and double-blind trial is expected to enroll 210 adolescents, between the ages of 12 to 17, who will receive doses of 10ug, 15ug or 30ug, and 140 children, between the ages of three to 11, who will receive doses of 10ug or 15ug.
Volunteers will be followed for two months with safety and immunogenicity data collected for the assessment of the vaccine. Sinovac received approval from the China State Food and Drug Administration in April 2007 to conduct clinical trials for two types of the H5N1 vaccine, namely Phase Ib and II trials of the H5N1 whole viron vaccine and Phase I and Phase II trials of the H5N1 split vaccine.
Weidong Yin, chairman, president and CEO of Sinovac, said: “Based on the positive safety results of the Phase I trial, the Phase II study will be conducted to further collect the vaccine’s safety data in children and adolescents, as well as assessing the immunogenicity of different doses.”