Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug

Recruiting now · Phase 3

Conditions studied: Infections, Meningococcal

In brief

Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug

Key facts

Study ID: NCT06834100
Run by: NPO Petrovax
People needed: 240
Starts: 2025-02-12
Expected to finish: 2025-12-31
Last updated by the study team: 2025-12-29

Who can join

Age: 3 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.
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).
Negative result of SARS-CoV-2 antigen rapid test at screening.
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.
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.
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.

You may not qualify if…

Hypersensitivity to any component of the test/reference drug.
Evident severe systemic reactions to any vaccines in anamnesis.
Impossibility of intramuscular injections.
Changes in the skin (pigmentation, tattoo, scars etc.) at the planned injection site of the test/reference drug (the deltoid muscle area).
Acute infectious and non-infectious diseases, exacerbation of chronic diseases at screening or less than 14 days before screening.
Body temperature measured in the armpit ≥ 37.0°C at Visits 0 and 1.
The history of chronic diseases that are significant in the opinion of the investigator (for example, malignant neoplasms, blood diseases, autoimmune diseases, immunodeficiencies, etc.).
The history of meningococcal infection.
Contact with a person with the confirmed infection caused by N. meningitidis less than 2 months before screening.
The history of convulsive syndrome or the advanced neurological disease.
The history of Guillain-Barré syndrome.
The history of mental diseases.
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.
Planning the administration of vaccines with the exception of the test/reference drug during the clinical study.
Surgical interventions performed less than 3 months before screening.
Participation in another clinical study less than 30 days before screening.
Other conditions that, in the opinion of the investigator, interfere to the enrollment.

Where it is running

Limited Liability Company "PiterClinic" — Saint Petersburg, Russia (enrolling)
Saint Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44" — Saint Petersburg, Russia (enrolling)
Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev" — Saransk, Russia (enrolling)
Limited Liability Company "DNA Research Center" — Saratov, Russia (enrolling)
Federal Budgetary Scientific Institution "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing — Moscow, Russia (enrolling)
Federal State Budgetary Educational Institution of Higher Education "Smolensk State Medical University" of the Ministry of Health of the Russian Federation — Smolensk, Russia (enrolling)
State Budgetary Healthcare Institution of Perm Krai "City Children's Clinical Polyclinic No. 5" — Perm, Russia (enrolling)
Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky" — Moscow, Russia (enrolling)
State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Healthcare Department" — Moscow, Russia (enrolling)
Limited Liability Company "Energy of Health" — Saint Petersburg, Russia (enrolling)
State Budgetary Healthcare Institution of the Sverdlovsk Region "Central City Hospital No. 7, Yekaterinburg" — Yekaterinburg, Russia
Federal State Budgetary Scientific Institution "I.I. Mechnikov Research Institute of Vaccines and Serums" — Moscow, 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 — Perm, Russia
Federal State Budgetary Institution "A. A. Smorodintsev Research Institute of Influenza" of the Ministry of Health of the Russian Federation — Saint Petersburg, Russia
Federal State Budgetary Institution "Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency" — Saint Petersburg, Russia
Limited Liability Company "DNA Research Center" — Saratov, Russia
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation — Kirov, Russia

Full record on ClinicalTrials.gov

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