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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9902 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-25

Study Completion Date

2023-07-19

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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SARS-CoV-2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

S-268019-b

Intervention Type DRUG

Solution for IM injection

Placebo

Intervention Type DRUG

Saline solution for IM injection

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.

Group Type EXPERIMENTAL

S-268019-b

Intervention Type DRUG

Solution for IM injection

Placebo

Intervention Type DRUG

Saline solution for IM injection

Interventions

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S-268019-b

Solution for IM injection

Intervention Type DRUG

Placebo

Saline solution for IM injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes