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

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212948
• Other study ID #: 2126U0232
• Status: Completed
• Phase: Phase 3
• Start date: December 25, 2021
• Est. completion date: July 19, 2023

Study information

• Verified date: July 2023
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9902
• Est. completion date: July 19, 2023
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Drug:
• S-268019-b
Solution for IM injection
• Placebo
Saline solution for IM injection

Locations

Country	Name	City	State
Vietnam	Buon Ma Thuot City Medical Center	Buon Ma Thuot City	Dak Lak

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With First Occurrence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 in the Initial Vaccination Period		14 days after the second dose administration
Secondary	Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period with Onset at Least 14 Days Following Second Vaccination		14 days after the second dose administration
Secondary	Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period		Up to Day 224
Secondary	Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period		Up to Day 224