Status:
COMPLETED
A Study of S-268019 for the Prevention of COVID-19
Lead Sponsor:
Shionogi
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
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 perio...
Eligibility Criteria
Inclusion
- Agree not to participate in any other SARS-CoV-2 prevention trial during the study follow-up.
- Capable of using Diary without difficulties (if applicable, with assistance by caregiver).
Exclusion
- Current or history of a laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
- Unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation.
- Immunosuppression (immunodeficiency, acquired immunodeficiency syndrome \[AIDS\], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy).
- Previous vaccination against SARS-CoV-2.
- Any inactivated vaccine received within 14 days prior to the first dose of study intervention.
- Any live vaccine received within 28 days prior to the first dose of study intervention.
- Immunoglobulin preparations, blood products, or a blood transfusion within 3 months prior to the first dose of study intervention.
- Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
December 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2023
Estimated Enrollment :
9902 Patients enrolled
Trial Details
Trial ID
NCT05212948
Start Date
December 25 2021
End Date
July 19 2023
Last Update
November 28 2025
Active Locations (1)
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1
Buon Ma Thuot City Medical Center
Buon Ma Thuot, Dak Lak, Vietnam