Drugs / S-268019-b
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05212948 | Dec 2021 → Dec 2022 | COVID-19 | Shionogi | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2022-03-04 | Shionogi | Results Shionogi Presents the Interim Report (Top-line Results) of a Phase 2/3 Additional Dose Clinical Trial for the COVID-19 Vaccine, S-268019 shionogi.com ↗
Regarding the GMT of the neutralizing antibody titer and the seroresponse rate of the SARS-CoV-2 neutralizing antibody titer on the 29th day (28 days after inoculation), the non-inferiority of the S-268019 group to the COMIRNATY group was confirmed, and this trial achieved the primary endpoint. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-03-04 | Shionogi | Shionogi Presents the Interim Report (Top-line Results) of a Phase 2/3 Additional Dose Clinical Trial for the COVID-19 Vaccine, S-268019 shionogi.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | S-268019-b | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05212948 ↗ |
| Modality | Vaccine | “A SARS-CoV-2 recombinant spike protein vaccine (S-268019-b) for COVID-19 prevention during the Omicron-dominant period: A phase 3, randomised, placebo-controlled clinical trial.” PMID 38734495 ↗ May 2024 |
| Route | Intramuscular | “participants received 2 intramuscular doses (28 days apart) of either 10 µg of S-268019-b (Recombinant S-protein vaccine) or placebo.” PMID 38734495 ↗ May 2024 |