Biopharmaceutical products company Sinovac Biotech Ltd (NASDAQ:SVA) on Thursday updated the preliminary results of its phase III clinical study of its Sabin inactivated polio vaccine (sIPV) on the unblinding conference held on 19 April 2018.
The preliminary results of the trial 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. The geometric mean titer (GMT) of three poliovirus types are all higher than the control vaccine.
In conjunction, the company will prepare the production license application of sIPV upon finalisation of the the clinical report.
This randomised, double-blind, controlled phase III clinical trial in Jiangsu province, China will evaluate the immunogenicity and safety of sIPV in two month-old infants. The trial commenced in 2017 with 12,00 healthy volunteers. The primary vaccination schedule sets three doses with a one month interval gaps.
Additionally, the company has signed a license agreement with Intravacc from Netherlands to develop and commercialise sIPV for distribution to China and other countries. Sinovac will commercialise the vaccine in China, inclusive of conducting clinical trials, obtaining regulatory approval and launching the sIPV. It has obtained the clinical license of sIPV in 2015. The phase I and phase II trials were completed in 2017.
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