Can a new vaccine shield adults from four meningitis strains?
NCT ID NCT06131554
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing an experimental vaccine called Menhycia, designed to protect against four types of meningococcal bacteria (A, C, Y, and W135) that can cause meningitis and bloodstream infections. The study involves about 1,480 healthy adults aged 18 to 55, who will receive either one dose of Menhycia or a licensed comparison vaccine. Researchers will measure the immune response and monitor for side effects to see if the new vaccine is as effective and safe as the existing one.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Group ACYW135 Meningococcal Conjugate Vaccine (CRM197), also known as Menhycia
- What this could lead to
- If successful, this vaccine could offer a new option to prevent meningococcal meningitis and septicemia caused by four serogroups (A, C, Y, W135) in adults.
- What could go wrong
- This is a Phase 3 trial, but results are not yet available. The vaccine may not produce a strong enough immune response or may cause side effects. Long-term protection is also unknown.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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1,480 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 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: * Participants aged 18-55 years old at the time of screening, who are in good health condition as determined by the study clinician. * Participants who have not been vaccinated with any meningococcal vaccines (including but not limited to meningococcal group A and C conjugate vaccine, meningococcal group A and C polysaccharide vaccine, Group ACYW135 Meningococcal polysaccharide/conjugate vaccine). * The participant or participant's legal guardian signs the informed consent form (ICF) and participant agrees to comply with the requirements of protocol and finish the 1-year follow-up. * Participants who are willing to discuss medical history with investigators or doctors and allow access to all medical records relevant to this trial. * Participants with child-bearing potential who are willing to practice adequate contraception methods from signing the ICF to 12 months after vaccination. This includes: 1. Abstinence from penile-vaginal intercourse, 2. Hormonal contraceptives such as oral contraceptives (the pill), injectables, implants, patches or estrogen vaginal ring (a ring-shaped hormonal contraceptive device that is used inside the vagina), 3. Intrauterine device (IUD/Spiral), 4. Male partner sterilization (vasectomy) prior to the female subject's entry into the study, and this male is the sole partner for that subject, 5. Male condom combined with a vaginal spermicide (a substance that can kill the sperm cells inside the vagina) or female diaphragm, whether with or without a vaginal spermicide . * Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial. Exclusion Criteria: * Axillary temperature \>37.5°C (99°F). * Have congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. * A history of epilepsy, convulsions or history/family history of mental illness. * Have meningitis or a history of meningitis illness. * Positive result of urine pregnancy test (also required for women within one year of menopause), lactating women, or participant /his partner is planning to become pregnant within 1 year. * Hypersensitivity to a component or excipient of the vaccine used in this clinical trial (mainly: group A, C, Y or W135 meningococcal capsular polysaccharide, diphtheria toxoid or diphtheria antigen, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate). * In the past 6 months (internal time \< 6 months), participants have received immunosuppressive treatment, cytotoxic treatment, glucocorticoid treatment, etc. (excluding local treatment, surface treatment of acute non-concurrent dermatitis, spray treatment of allergic rhinitis). * Received or plan to receive blood/plasma products or immunoglobulins throughout the study period or 60 days prior to study vaccination. * Use of non-prescription drugs such as antipyretic (e.g., acetaminophen) and anti-inflammatory drugs (e.g., ibuprofen, naproxen etc.) within 12 hours before the administration of vaccine. * Have severe hypertension that is not controlled by medication (at the time of field measurement: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg). * Suffering from a severe chronic disease or a condition that is in a progressive stage and cannot be well controlled, such as thyroid disease * Participants with known or suspected diseases that are judged by the investigator to affect the vaccination assessment, for example, acute infectious diseases, severe respiratory disease, severe cardiovascular disease, severe allergic skin disease etc. * History of serious adverse reactions associated with the vaccine and/or history of severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine. * Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., HIV infection, history of pancreatic, liver, spleen, kidney disease or history of resection). * Positive for HIV, Hepatitis B, Hepatitis C or Syphilis. * Bleeding constitution or condition associated with prolonged bleeding for which intramuscular injection is contraindicated in the opinion of the investigator. * Administration of live attenuated vaccine within 14 days or other vaccines within 7 days. * Participation in other studies involving interventional studies within 28 days prior to screening and/or during study participation. * According to the judgment of the investigator, participants could be excluded due to various medical, psychological, social or other conditions that are contrary to the trial protocol or that affect the subject's ability to sign informed consent. * Investigator site staff directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members,sponsor staff and their respective family members.
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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.
Contacts and locations
Locations
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Husada Utama Hospital
Surabaya, 60131, Indonesia
More trials for these conditions
Other studies related to the condition(s) this trial covers.