NCT05212948

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

A Phase 3, Randomized, Observer-Blind, Placebo- Controlled Cross-over Study to Evaluate the Efficacy, Safety, and Immunogenicity of S-268019 for the Prevention of COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9,902 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Eligible participants will be randomized to receive either S-268019-b or placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods, an initial vaccination period (Day 1 to Day 224), and a crossover vaccination period (Day 225 to Day 435).

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	S-268019-b	Solution for IM injection
DRUG	Placebo	Saline solution for IM injection

Timeline

• Start date: 2021-12-25
• Primary completion: 2022-12-19
• Completion: 2023-07-19
• First posted: 2022-01-28
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

1 site across 1 country: Vietnam