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Tests treatment safety and results for Meningococcal Infections
Official title Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old
ClinicalTrials.gov ID: NCT07204457
What this study is testing
What is EG-MCV4?
EG-MCV4 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for meningococcal infections.
Also referred to as Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 2/3 study to evaluate immunogenicity and safety in healthy adult participants following a single dose administration of Meningococcal (groups A, C, W-135, and Y) conjugate vaccine
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Individuals who are available for all scheduled visits, including phone calls and in-person appointments, for the duration of the study.
You likely can't join if
- 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...
- History of Hepatitis B or C at the time of screening.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.