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New COVID-19 vaccine shows promise in large trial

NCT ID NCT05212948

Prevention Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested a new COVID-19 vaccine called S-268019-b in nearly 10,000 adults. Participants received either the vaccine or a placebo to see if it could prevent COVID-19. The study looked at how many people got sick after vaccination and checked for safety and immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
S-268019-b vaccine
What this could lead to
If successful, this vaccine could help prevent COVID-19, reducing infections and severe illness.
What could go wrong
This trial is completed, but results may not apply to new variants. As with any vaccine, there is a small risk of side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

9,902 people

The number who actually took part.

Started

Dec 2021

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV-2

Contacts and locations

Locations

  • Buon Ma Thuot City Medical Center

    Buon Ma Thuot, Dak Lak, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.