New vaccine aims to shield against deadly meningitis strains
NCT ID NCT07204457
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 1,123 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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19 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The Catholic University of Eunpyeong St.Mary's Hospital
RECRUITINGSeoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.