Sinovac Biotech provides pipeline update
Sinovac Biotech provided an update on the company's pipeline vaccines. Sabin-inactivated polio vaccine, or sIPV: The company initiated the phase I clinical trial in October 2016. The phase I trial is designed to assess the safety and tolerance of the vaccine candidates. Subjects include adults aged 18-49 years old, young children aged 6-12 years old, and infants aged two months old for a total of 108 volunteers. The phase II trial is expected to be launched after the preliminary results of phase I trials are available. For Phase II, 600 infants are expected to be enrolled to select the objective dosage and assess immunogenicity with a blinded, randomized and controlled design. The phase II clinical trial is expected to be completed in Q3 of 2017. The phase III clinical trial is expected to assess the immunogenicity and safety with the vaccine candidate of the selected dosage from the phase II trial. Sinovac originally obtained approval for sIPV clinical trials in December 2015. Varicella vaccine: The company completed the phase I clinical trial in Henan Province with results showing that the varicella vaccine candidate has a good safety profile. In Q3 of 2016, the company initiated the phase III clinical trial, which measures efficacy and immunogenicity with a randomized, double-blind, parallel-treatment, placebo-controlled study in addition to safety. Over 6,000 subjects aged from one to twelve years old have been enrolled as volunteers for the phase III clinical trial. Sinovac obtained approval to commence human clinical trials in 2015.