Track 14: Vaccines Production and Clinical trials
This research in virology is a phase III clinical trial that is randomized, double-blinded, multi-center, and placebo-controlled for individuals ages 18 to 59. This investigation's goal is to assess the SARS-CoV-2 inactivated vaccine's effectiveness, safety, and immunogenicity. Sinovac Research & Development Co., Ltd. produced both the experimental vaccination and a placebo. 13.000 subjects in total will be registered. On the scheduled day of day 0,14, the subject will either be given two doses of the experimental vaccination or a placebo. The trial will involve two distinct cohorts, as anticipated.
Healthcare professionals in the high-risk category (K-1) will make up the first cohort, while those at normal risk will make up the second cohort (K-2). After 1300 participants have had their second round of vaccination, the safety data will be reviewed by the data safety monitoring board without compromising the blinding process. If there are no safety concerns, the K2 cohort will continue to receive vaccinations. The K-1 cohort will have 1.300 participants, 650 of whom will participate in the SARS-CoV-2 vaccination and placebo arms. It was intended to include 7.650 participants in the SARS-CoV-2 vaccination group and 3.500 volunteers in the placebo group in the K-2 cohort (the typical risk category for COVID-19).