Phase III trials of sIPV shows vaccine effective in polio.- Sinovac Biotec.
Sinovac Biotech announced preliminary results of a phase III clinical study on sIPV (sabin inactivated polio vaccine) developed by Sinovac Biotech on the unblinding conference held on April 19, 2018. The preliminary results of the trial after unblinding show the seroconversion rate of poliovirus type II is superior to the control vaccine and seroconversion rates of the other two types of poliovirus are non-inferior to the control vaccine. And geometric mean titer of three poliovirus types are all higher than the control vaccine.
The Company will prepare the production license application after the clinical report is finalized. The phase III trial is a randomized, double-blind, controlled clinical trial to evaluate the immunogenicity and safety of sIPV in 2-month-old infants. The trial commenced in August 2017 with twelve hundred healthy volunteer subjects enrolled in the study. The primary vaccination schedule sets three doses with a one month interval between doses and the trial was carried out in Jiangsu province, China.
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