Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05212948
Recruitment Status : Active, not recruiting
First Posted : January 28, 2022
Last Update Posted : April 6, 2023
Sponsor:
Information provided by (Responsible Party):
Shionogi Inc. ( Shionogi )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 before vaccination as compared to placebo.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: S-268019-b Drug: Placebo Phase 3

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).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54915 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : December 25, 2021
Actual Primary Completion Date : December 19, 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: S-268019-b, Then Placebo
Participants will first receive a dose of S-268019-b via intramuscular (IM) injection on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive a placebo IM injection (matching S-268019-b) on Day 225 and Day 253.
 Drug: S-268019-b
Solution for IM injection

Drug: Placebo
Saline solution for IM injection
Experimental: Placebo, Then S-268019-b
Participants will first receive a dose of placebo IM injection (matching S-268019-b) on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive S-268019-b IM injection on Day 225 and Day 253.
 Drug: S-268019-b
Solution for IM injection

Drug: Placebo
Saline solution for IM injection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 [ Time Frame: 14 days after the second dose administration ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 14 days after the second dose administration ]
  2. Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period [ Time Frame: Up to Day 224 ]
  3. Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period [ Time Frame: Up to Day 224 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05212948


Locations
Layout table for location information
Vietnam
Buon Ma Thuot City Medical Center
Buon Ma Thuot City, Dak Lak, Vietnam
Sponsors and Collaborators
Shionogi
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Shionogi
ClinicalTrials.gov Identifier: NCT05212948    
Other Study ID Numbers: 2126U0232
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: April 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No