Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT07204457
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT07204457
Study Brief:
Protocol Section:
NCT07204457