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New meningitis vaccine trial aims to protect 240 volunteers

NCT ID NCT06834100

Vaccine Sponsor: NPO Petrovax Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new vaccine called GNG-DE to see how well it protects against meningococcal infections (a cause of meningitis). About 240 people aged 3 to 55 will receive either the new vaccine or a reference vaccine. Researchers will measure immune responses and check for side effects.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

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

3 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: 1. Male and female subjects aged 3-55 years old inclusive at the time of screening beginning. 2. Availability of a signed Volunteer Informed Consent Form (Volunteer Information Sheet, VIS) (for participants aged 7-55 years inclusive) and/or the parent/adoptive parent informed consent form (Parent Information Sheet, PIS) signed by one of parents/adoptive parents (for participants aged 3-17 years old inclusive). 3. Negative result of SARS-CoV-2 antigen rapid test at screening. 4. Negative pregnancy test result in fertile females of reproductive age. For females not reached puberty, and for girls/women unable to childbirth (with past infertility, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, menopause for more than 2 years), the pregnancy test shall not be performed. 5. For participants of 14-55 years old inclusive with preserved reproductive function, the consent to use of reliable methods of contraception (abstinence, condoms in combination with spermicide and/or hormonal contraception) during the study. For participants aged 3-13 years old inclusive and females incapable of childbearing, the consent to use reliable methods of contraception is not required. 6. The consent of a participant and/or a parent/an adoptive parent of a participant to cooperate in good faith with the investigator and the center staff, come to appointed visits, fill out the observation diary and comply with the requirements of the Protocol. Exclusion Criteria: 1. Hypersensitivity to any component of the test/reference drug. 2. Evident severe systemic reactions to any vaccines in anamnesis. 3. Impossibility of intramuscular injections. 4. Changes in the skin (pigmentation, tattoo, scars etc.) at the planned injection site of the test/reference drug (the deltoid muscle area). 5. Acute infectious and non-infectious diseases, exacerbation of chronic diseases at screening or less than 14 days before screening. 6. Body temperature measured in the armpit ≥ 37.0°C at Visits 0 and 1. 7. The history of chronic diseases that are significant in the opinion of the investigator (for example, malignant neoplasms, blood diseases, autoimmune diseases, immunodeficiencies, etc.). 8. The history of meningococcal infection. 9. Contact with a person with the confirmed infection caused by N. meningitidis less than 2 months before screening. 10. The history of convulsive syndrome or the advanced neurological disease. 11. The history of Guillain-Barré syndrome. 12. The history of mental diseases. 13. Drug administration: * the history of meningococcal mono- or polyvalent vaccine, influenza vaccine within 14 days before screening, other vaccines within 30 days before screening; * immunostimulants less than 30 days before screening; * the immunosuppressive therapy, including systemic corticosteroids, prescribed for more than 5 days, or in the daily dose of more than 1 mg/kg/day of prednisolone or its equivalent - less than 30 days before screening; * antipyretics, analgesics - for less than 24 hours before Visits 0 and 1; * systemic antibacterial drugs-- for less than 72 hours before Visits 0 and 1; * anticoagulants - for less than 3 weeks before Visits 0 and 1; * immunoglobulins, blood or plasma products - for less than 3 months before Visits 0 and 1. 14. Planning the administration of vaccines with the exception of the test/reference drug during the clinical study. 15. Surgical interventions performed less than 3 months before screening. 16. Participation in another clinical study less than 30 days before screening. 17. Other conditions that, in the opinion of the investigator, interfere to the enrollment.

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Conditions

The condition(s) this trial relates to.

Infections infectious disease meningococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infections Meningococcal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Federal Budgetary Scientific Institution "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing

    RECRUITING

    Moscow, Russia

  • Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation

    COMPLETED

    Kirov, Russia

  • Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev"

    RECRUITING

    Saransk, Russia

  • Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after Academician E.A. Wagner" of the Ministry of Health of the Russian Federation

    COMPLETED

    Perm, Russia

  • Federal State Budgetary Educational Institution of Higher Education "Smolensk State Medical University" of the Ministry of Health of the Russian Federation

    RECRUITING

    Smolensk, Russia

  • Federal State Budgetary Institution "A. A. Smorodintsev Research Institute of Influenza" of the Ministry of Health of the Russian Federation

    COMPLETED

    Saint Petersburg, Russia

  • Federal State Budgetary Institution "Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency"

    COMPLETED

    Saint Petersburg, Russia

  • Federal State Budgetary Scientific Institution "I.I. Mechnikov Research Institute of Vaccines and Serums"

    COMPLETED

    Moscow, Russia

  • Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky"

    RECRUITING

    Moscow, Russia

  • Limited Liability Company "DNA Research Center"

    RECRUITING

    Saratov, Russia

  • Limited Liability Company "DNA Research Center"

    COMPLETED

    Saratov, Russia

  • Limited Liability Company "Energy of Health"

    RECRUITING

    Saint Petersburg, Russia

  • Limited Liability Company "PiterClinic"

    RECRUITING

    Saint Petersburg, Russia

  • Saint Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44"

    RECRUITING

    Saint Petersburg, Russia

  • State Budgetary Healthcare Institution of Perm Krai "City Children's Clinical Polyclinic No. 5"

    RECRUITING

    Perm, Russia

  • State Budgetary Healthcare Institution of the Sverdlovsk Region "Central City Hospital No. 7, Yekaterinburg"

    COMPLETED

    Yekaterinburg, Russia

  • State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Healthcare Department"

    RECRUITING

    Moscow, Russia

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Other studies related to the condition(s) this trial covers.