Japanese pharma major Shionogi (TYO: 4507) today announced the interim report of a Phase II/III additional dose clinical trial of S-268019, a preventive vaccine for COVID-19.
This adds to Shionogi’s coronavirus pipeline, which includes S-217622, an orally administered antiviral drug for COVID-19, on which the company last month reported Phase IIa results and submission for regulatory review.
The primary endpoint of the Phase II/III additional clinical trial is the geometric mean antibody titer (GMT) of neutralizing antibody titer and seroresponse rate of SARS-CoV-2 neutralizing antibody titer on the 29th day (28 days after inoculation). The non-inferiority of immunogenicity compared to Comirnaty intramuscular injection when S-268019 or Comirnaty was vaccinated for the third time in 206 adults, six months or more after receiving two inoculations of Comirnaty, as well as safety were evaluated.
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