https://www1.hkexnews.hk/listedco/listc ... 100115.pdf... The Company is pleased to announce that it has been informed by the IDMC that Ad5-nCoV has
successfully met its pre-specified primary safety and efficacy criteria at this interim analysis. There were
no vaccine related serious adverse events (“SAE”) and therefore the Company could continue to advance the phase III clinical trial of Ad5-nCoV. As at the date of this announcement, the Company remains blinded to whether the participants involved in the trial received vaccine or placebo. Further announcement(s) regarding the details and developments of the phase III clinical trial of Ad5-nCoV will be made by the Company as and when appropriate.
Information about the phase III clinical trial of Ad5-nCoV
This phase III clinical trial of Ad5-nCoV is a global multicenter, randomized, double-blind, placebocontrolled, adaptive designed phase Ⅲ clinical trial to evaluate the efficacy, safety and immunogenicity of Ad5-nCoV in adults 18 years of age and older. All participants received a single dose of either Ad5-nCoV or a placebo vaccine on Day 0 and will be followed to monitor vaccine candidate efficacy and incidence of SAE for a duration of 52 weeks. The primary efficacy objective is the efficacy of Ad5-nCoV in preventing virologically confirmed (PCR positive) symptomatic COVID-19 disease, regardless of severity, occurring 28 days to 52 weeks after vaccination. COVID-19 disease rates in Ad5-nCoV group will be compared with COVID-19 rates in the control group. The primary safety objective is to evaluate the incidence of SAE and medically attended adverse events within 52 weeks after vaccination in all participants.
The phase III clinical trial of Ad5-nCoV has vaccinated more than 40,000 volunteers in 78 clinical trial sites across five countries over three continents, which is led by global principal investigator (“PI”), global co-PI and country co-PI from seven countries, and strictly complies with high ethical standards and rigorous scientific principles.