Past development of COVID-19 vaccines has usually entailed large-scale clinical trials to evaluate the onset prevention effect. However, as effective vaccines have become broadly distributed and more and more of the population has been vaccinated, it has become difficult to carry out onset prevention studies.?At the same time, substantial demand remains for additional, and even initial, vaccine doses globally; therefore, it is necessary to develop safe and effective new vaccines. Under these circumstances, to progress the development of a new vaccine against COVID-19, the neutralizing antibody titer after vaccination can be used as a substitute index for the onset prevention effect. After discussions at the
The phase 3 clinical trial that started in
About a Japanese Phase 1/2 clinical trial2
The Phase 1/2 clinical trial is double-blind and placebo-controlled study to evaluate safety, tolerability and immunogenicity of two doses of the vaccine. 60 adults are enrolled in the trial. For more information about this clinical trial, please refer to jRCT No.:2031210269. Subject registration for this trial has been completed. In the evaluation up to 28 days of two doses of the vaccine, confirmed tolerability and safety, neutralizing antibody titer equal to or higher than that of convalescent serum.
About a Japanese Phase 2/3 clinical trial3
The Phase 2/3 clinical trial is a open-label study to evaluate safety, tolerability and immunogenicity of s-268019 in 3,100 adults and elderly people. For more information about this clinical trial, please refer to jRCT No.:2031210383. Subject registration for this trial has been completed.
About Phase 3 additional dose clinical trial4
This clinical trial is a randomized, active controlled, double-blind trial. In this trial, the efficacy and safety of an additional dose of Comirnaty or S-268019 in 200 adults, 6 months or more after receiving a primary series of Comirnaty, will be compared.. For more information about this clinical trial, please refer to jRCT No.:2031210470. Subject registration for this trial has been completed.
About Phase 3 active control neutralizing antibody comparative clinical trial
This clinical trial is a double-blind randomized active controlled trial to evaluate a neutralizing antibody titer after the primary series of Vaxzevria or S-268019 in 1,000 adults and the elderly people.For more information about this clinical trial, please refer to jRCT No.: 2051210151.
About Global Phase 3 placebo-controlled onset prevention clinical trial5
This clinical trial is a randomized, placebo-controlled, double-blind trial to evaluate the onset prevention effect for COVID-19 after primary series of S-268019 compared with placebo. Approximately 50,000 adults and the elderly people will be enrolled and randomly assigned 2:1 to S-268019 and placebo. This clinical trial adopted crossover assignment, then all participant can get an opportunity to access active control. Currently, we are proceeding with subject registration in
In any clinical trial, subjects can decline to participate in the trial at any time during the trial period if they want.
Phase 1/2 Clinical Trial was supported by
Our efforts against COVID-19 are updated on our website, as needed. A considerable amount of valuable information on COVID-19 from other websites is also summarized on this page, so please use it for reference:
For Further Information:
SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html
Contact:
General
Shionogi Europe
T: +44 (0)20 3053 4200
T: +39 06 8767 8601
T: + 49 (0)30 2062980-10
T: +34 91 7697 325
(C) 2022 Electronic News Publishing, source