Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug
NCT ID: NCT06834100
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2025-02-12
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
The 1st group (n=40) of participants will receive the drug GNG-DE in a dose of 0.5 ml intramuscularly into the deltoid muscle area.
The 2nd group (n=40) of participants will receive Menactra® in a dose of 0.5 ml intramuscularly into the deltoid muscle area.
This study will be conducted as a single blind study, i.e. The study physician will know, but the subject will not know, which drug (study or reference drug) will be administered.
Study Groups
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Stage I
At this stage, adult volunteers aged 18-55 years old (inclusive) will be enrolled in the study. After screening procedures, 80 volunteers who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1: 1 ratio
polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Group 1 (n = 40) will receive GNG-DE at a dose of 0.5 mL intramuscularly into the deltoid site.
Group 2 (n = 40) will receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.
Stage II
Stage II will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage I data. At this stage, adolescents aged 11-17 years old (inclusive) will be included in the study. After screening procedures, 80 adolescents who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratio
polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Group 1 (n = 40) will receive GNG-DE at a dose of 0.5 mL intramuscularly into the deltoid site.
Group 2 (n = 40) will receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.
Stage III
Stage III will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage II data. At this stage, children aged 3-10 years old (inclusive) will be included in the study. After screening procedures, 80 children who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratiowill receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.
polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Group 1 (n = 40) will receive GNG-DE at a dose of 0.5 mL intramuscularly into the deltoid site.
Group 2 (n = 40) will receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.
Interventions
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polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y
Group 1 (n = 40) will receive GNG-DE at a dose of 0.5 mL intramuscularly into the deltoid site.
Group 2 (n = 40) will receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Years
55 Years
ALL
Yes
Sponsors
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NPO Petrovax
INDUSTRY
Responsible Party
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Locations
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Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation
Kirov, , Russia
Federal Budgetary Scientific Institution "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing
Moscow, , Russia
Federal State Budgetary Scientific Institution "I.I. Mechnikov Research Institute of Vaccines and Serums"
Moscow, , Russia
Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky"
Moscow, , Russia
State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Healthcare Department"
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
State Budgetary Healthcare Institution of Perm Krai "City Children's Clinical Polyclinic No. 5"
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 "Energy of Health"
Saint Petersburg, , Russia
Limited Liability Company "PiterClinic"
Saint Petersburg, , Russia
Saint Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44"
Saint Petersburg, , Russia
Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev"
Saransk, , Russia
Limited Liability Company "DNA Research Center"
Saratov, , Russia
Limited Liability Company "DNA Research Center"
Saratov, , Russia
Federal State Budgetary Educational Institution of Higher Education "Smolensk State Medical University" of the Ministry of Health of the Russian Federation
Smolensk, , Russia
State Budgetary Healthcare Institution of the Sverdlovsk Region "Central City Hospital No. 7, Yekaterinburg"
Yekaterinburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Aleksandr Gorelov, Doctor of Medical Sciences
Role: primary
Leyla Namazova-Baranova, Doctor of Medical Sciences
Role: primary
Alexey Rtishchev, Candidate of Medical Sciences
Role: primary
Olga Perminova, Candidate of Medical Sciences
Role: primary
Svetlana Lazareva
Role: primary
Tatiana Pak, Candidate of Medical Sciences
Role: primary
Olga Trusova, Doctor of Medical Sciences
Role: primary
Svetlana Garina, Candidate of Medical Sciences
Role: primary
Lubov Aleshina, Candidate of Medical Sciences
Role: primary
Elena Kozlova, Candidate of Medical Sciences
Role: primary
Other Identifiers
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GNG-DE-III-24
Identifier Type: -
Identifier Source: org_study_id