Meningococcal InfectionsPhase 2/3NCT07204457
Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old
A Phase 2/3 study testing EG-MCV4 and Menveo in people with Meningococcal Infections, run by EyeGene Inc. at 1 site in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections
- What is being tested?
- EG-MCV4 and Menveo
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,123 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2025to Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Eunpyeong St.Mary's Hospital
Seoul
About this study
Official title: Multicenter, Randomized, Subject/Evaluator Blind, Active Control, Phase II/III Clinical Trial to Assess Immunogenicity and Safety of EG-MCV4 Meningococcal (Groups A, C, W-135, and Y) Conjugated Vaccines
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
- Conditions
- Meningococcal Infections
- Being tested
- EG-MCV4, Menveo
- Keywords
- Meningococcal Vaccines, Vaccines, Conjugate, Bacterial Vaccines, Vaccines, Bacterial Infections, Meningococcal Disease, Neiseriaceae Infections, Gram-Negative Bacterial Infections, Infections, Biological Products
- Medical subject headings
- Meningococcal Infections, Bacterial Infections, Gram-Negative Bacterial Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG-MCV4Biological
Also called Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine
single intramuscular dose on Day 0
MenveoBiological
Also called Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine
single intramuscular dose on Day 0
| Study group | Role | What they receive |
|---|---|---|
| EG-MCV4 (Test group 1) | Experimental | Healthy adults received 0.5 mL single intramuscular dose on Day 0. Receives: Biological: EG-MCV4 |
| EG-MCV4 (Test group 2) | Experimental | Healthy adults received 0.25 mL single intramuscular dose on Day 0. Receives: Biological: EG-MCV4 |
| Menveo | Active comparator | Healthy adults received 0.5 mL single intramuscular dose on Day 0. Receives: Biological: Menveo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroresponse
- Part 1:
- The proportion of subjects achieving a seroresponse as measured by hSBA and rSBA
- Part 2:
- The proportion of subjects achieving a seroresponse as measured by rSBA
Measured: 28 days after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Oct 2025
- Primary completionSep 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EyeGene Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- BMI Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204457
- Sponsor's protocol ID
- EG-MCV4-P3
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Subject/Evaluator Blind, Active Control, Phase II/III Clinical Trial to Assess Immunogenicity and Safety of EG-MCV4 Meningococcal (Groups A, C, W-135, and Y) Conjugated Vaccines
- ClinicalTrials.gov ID
- NCT07204457
- Acronym / sponsor ID
- EG-MCV4-P3
- Conditions
- Meningococcal Infections
- Keywords
- Meningococcal Vaccines, Vaccines, Conjugate, Bacterial Vaccines, Vaccines, Bacterial Infections, Meningococcal Disease, Neiseriaceae Infections, Gram-Negative Bacterial Infections
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,123 participants (estimated)
- Lead sponsor
- EyeGene Inc.University, hospital or other
- Collaborators
- BMI Korea
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EG-MCV4 (Test group 1) | Experimental | Biological: EG-MCV4Healthy adults received 0.5 mL single intramuscular dose on Day 0. |
| EG-MCV4 (Test group 2) | Experimental | Biological: EG-MCV4Healthy adults received 0.25 mL single intramuscular dose on Day 0. |
| Menveo | Active comparator | Biological: MenveoHealthy adults received 0.5 mL single intramuscular dose on Day 0. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EG-MCV4Also: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccinesingle intramuscular dose on Day 0 | Biological | EG-MCV4 (Test group 1), EG-MCV4 (Test group 2) |
| MenveoAlso: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccinesingle intramuscular dose on Day 0 | Biological | Menveo |
Primary outcome
Seroresponse
Time frame: 28 days after the vaccination
* Part 1: * The proportion of subjects achieving a seroresponse as measured by hSBA and rSBA * Part 2: * The proportion of subjects achieving a seroresponse as measured by rSBA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EG-MCV4 and Menveo in people with Meningococcal Infections, run by EyeGene Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jooyoung Park (+82-2-322-1687, jypark@eyegene.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroresponse (time frame: 28 days after the vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.