CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9,902 enrolled
Drug / intervention
S-268019-b +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05212948
NCT05212948Phase 3Completed

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

Shionogi·interventional·Posted Jan 28, 2022·Updated Nov 28, 2025

In Brief

A Phase 3 clinical trial evaluating S-268019-b and Placebo for SARS-CoV-2. Completed, enrolled 9,902 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2
CountriesVietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJan 28, 2022
Enrollment StartDec 25, 2021
Primary CompletionDec 19, 2022
Study CompletionJul 19, 2023
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.4 years ago

Interventions

S-268019-bdrug

Solution for IM injection

Placebodrug

Saline solution for IM injection