New vaccine aims to shield against deadly meningitis strains

NCT ID NCT07204457

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new vaccine designed to protect against four types of meningococcal bacteria that can cause serious infections like meningitis and sepsis. About 1,100 healthy adults aged 19 to 55 will receive a single dose to see how well it triggers the immune system and if it is safe. The goal is to find a better option to prevent these life-threatening diseases.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,123 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

19 to 55 years

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: * Healthy males and females aged 19 to 55 years. * Individuals who have been fully informed about the clinical trial, understand the details, and voluntarily agree to participate by providing written informed consent. * Individuals who are available for all scheduled visits, including phone calls and in-person appointments, for the duration of the study. Exclusion Criteria: * History of prior disease caused by N. meningitidis. * Contact with a person infected with N. meningitidis within 60 days of screening. * Prior receipt of a meningococcal vaccine or a vaccine containing a meningococcal antigen. * History of or planned vaccination with any other vaccine within 4 weeks before or after administration of the investigational product. * History of fever (≥ 38°C) within 3 days of screening, or a history of a significant acute infectious disease within 7 days of screening, or a chronic infectious disease within 4 weeks of screening. * History of Hepatitis B or C at the time of screening. * Presence of any significant acute, chronic, or progressive disease that, in the opinion of the investigator, could interfere with the conduct or completion of the study. * History of malignancy or high-risk malignant disease within 5 years before the investigational product administration. * History of epilepsy, progressive neurological disease, or Guillain-Barré Syndrome. * History of anaphylaxis. * History of systemic urticaria within 5 years of the investigational product administration. * Hypersensitivity to the active substance, diphtheria toxoid (CRM197), or any other excipient, or a history of a life-threatening reaction to a vaccine containing similar components. * Hypersensitivity to the investigational vaccine, any of its components, or latex. * History of any therapy that could affect the immune system within 6 months of screening. * History of immunodeficiency disease, or a family history of such a disease. * Receipt of any parenteral immunoglobulin preparation, blood product, or plasma derivatives within 90 days of screening, or planned administration during the study period. * History of platelet-related or hemorrhagic disorders or a history of excessive bleeding or bruising after intramuscular injection or venipuncture. * Current treatment with anticoagulants or new antiplatelet agents. * History of organ or bone marrow transplantation. * Suspected history of drug or alcohol abuse within 1 year before the investigational product administration. * Individuals unwilling to use a medically acceptable method of contraception for the duration of the clinical trial. * Pregnant or lactating women. * Receipt or planned receipt/application of another investigational drug or medical device within 6 months prior to study participation. * Presence of a significant abnormality on a screening test, or any other reason that, in the opinion of the investigator, makes the individual unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Catholic University of Eunpyeong St.Mary's Hospital

    RECRUITING

    Seoul, South Korea

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