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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05212948
Other study ID # 2126U0232
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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