A Study of S-268019 for the Prevention of COVID-19

Phase 3 Completed 9902 enrolled Shionogi

RandomizedCrossoverTriple-blindPrevention

Summary

The main purpose of this study is to assess the efficacy of S-268019-b for the prevention of COVID-19 in the initial vaccination period prior to crossover in participants without evidence of infection before vaccination as compared to placebo.

Timeline

Start: 2021-12-25
Primary completion: 2022-12-19
Completion: 2023-07-19

Outcome

Missed primary endpoint

registry analysis (other test); S-268019-b vs Placebo; p = 0.2409; Efficacy 34.2 (95% CI 21.9 to 44.6) NCT05212948 ↗

paper S-268019-b did not demonstrate the targeted efficacy threshold against symptomatic COVID-19; PMID 38734495 ↗

Publications

Results Dinh Thiem V, Van Anh PT, Van Men C, Hung DT, Pollard AJ, Kamitani A, Tada Y, Fukuyama H, Iwasaki Y, Ariyasu M, Sonoyama T. 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. Vaccine. 2024 Jun 20;42(17):3699-3709. doi: 10.1016/j.vaccine.2024.04.084. Epub 2024 May 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	S-268019-b	Vaccine	10 ug	Intramuscular