Actively Recruiting
Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug
Led by NPO Petrovax · Updated on 2025-12-29
240
Participants Needed
17
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug
CONDITIONS
Official Title
Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.
- Signed informed consent form by participant (if aged 7-55 years) or parent/adoptive parent (if aged 3-17 years).
- Negative SARS-CoV-2 antigen rapid test at screening.
- Negative pregnancy test in fertile females of reproductive age; not required for prepubescent girls or females unable to bear children.
- For participants aged 14-55 years with preserved reproductive function, agreement to use reliable contraception during the study.
- Agreement to cooperate with investigators, attend visits, complete observation diary, and follow study protocol requirements.
You will not qualify if you...
- Allergy to any component of the test or reference vaccine.
- Severe systemic reactions to any vaccine in medical history.
- Inability to receive intramuscular injections.
- Skin changes at the injection site (pigmentation, tattoo, scars).
- Acute infectious or non-infectious diseases or exacerbation of chronic diseases within 14 days before screening.
- Body temperature at or above 37.0°C at Visits 0 and 1.
- Significant chronic diseases as judged by the investigator (e.g., cancer, blood diseases, autoimmune diseases, immunodeficiencies).
- History of meningococcal infection.
- Contact with someone infected by N. meningitidis within 2 months before screening.
- History of convulsive syndrome or advanced neurological disease.
- History of Guillain-Barré syndrome.
- History of mental illnesses.
- Recent drug administration: meningococcal or influenza vaccines within 14 days; other vaccines within 30 days; immunostimulants within 30 days; immunosuppressive therapy within 30 days; antipyretics or analgesics within 24 hours before Visits 0 and 1; systemic antibiotics within 72 hours before Visits 0 and 1; anticoagulants within 3 weeks before Visits 0 and 1; immunoglobulins or blood products within 3 months before Visits 0 and 1.
- Planned administration of other vaccines during the study except the test or reference drug.
- Surgery within 3 months before screening.
- Participation in another clinical study within 30 days before screening.
- Other conditions interfering with enrollment as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation
Kirov, Russia
Completed
2
Federal Budgetary Scientific Institution "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing
Moscow, Russia
Actively Recruiting
3
Federal State Budgetary Scientific Institution "I.I. Mechnikov Research Institute of Vaccines and Serums"
Moscow, Russia
Completed
4
Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky"
Moscow, Russia
Actively Recruiting
5
State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children's City Clinical Hospital of the Moscow City Healthcare Department"
Moscow, Russia
Actively Recruiting
6
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
Completed
7
State Budgetary Healthcare Institution of Perm Krai "City Children's Clinical Polyclinic No. 5"
Perm, Russia
Actively Recruiting
8
Federal State Budgetary Institution "A. A. Smorodintsev Research Institute of Influenza" of the Ministry of Health of the Russian Federation
Saint Petersburg, Russia
Completed
9
Federal State Budgetary Institution "Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency"
Saint Petersburg, Russia
Completed
10
Limited Liability Company "Energy of Health"
Saint Petersburg, Russia
Actively Recruiting
11
Limited Liability Company "PiterClinic"
Saint Petersburg, Russia
Actively Recruiting
12
Saint Petersburg State Budgetary Healthcare Institution "Children's City Polyclinic No. 44"
Saint Petersburg, Russia
Actively Recruiting
13
Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev"
Saransk, Russia
Actively Recruiting
14
Limited Liability Company "DNA Research Center"
Saratov, Russia
Actively Recruiting
15
Limited Liability Company "DNA Research Center"
Saratov, Russia
Completed
16
Federal State Budgetary Educational Institution of Higher Education "Smolensk State Medical University" of the Ministry of Health of the Russian Federation
Smolensk, Russia
Actively Recruiting
17
State Budgetary Healthcare Institution of the Sverdlovsk Region "Central City Hospital No. 7, Yekaterinburg"
Yekaterinburg, Russia
Completed
Research Team
K
Kirill Klimkin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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