Actively Recruiting
Simple Blinded Multicenter Randomized Comparative Study to Assess Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE
Led by NPO Petrovax · Updated on 2025-12-29
240
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immune response, side effects, and safety of a vaccine called GNG-DE compared to a reference vaccine for preventing meningococcal infections. This phase 3 trial is conducted by NPO Petrovax and involves healthy volunteers aged 3 to 55 years. The study is divided into three stages to include adults, adolescents, and children sequentially, with each stage beginning after safety review of the previous stage. Participants are randomly assigned to one of two groups to receive either GNG-DE or the reference vaccine Menactra®, both given as 0.5 mL injections into the muscle of the upper arm. The study starts with adults aged 18 to 55 years, then moves to adolescents aged 11 to 17 years, and finally to children aged 3 to 10 years. Each group includes 80 participants, and the dosing and administration are consistent across all age groups. Throughout the study, volunteers undergo screening before enrollment and attend scheduled visits for safety and immune response assessments. The main outcome measured is the primary immune response 29 days after vaccination. Additional immune markers and safety data are also collected. Participants will be monitored closely to track any reactions or side effects, with all procedures conducted under medical supervision until the study ends in late 2025.
CONDITIONS
Brief 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 to 55 years old inclusive at the time of screening beginning
- Signed informed consent from the participant (ages 7 to 55) or from a parent/adoptive parent (ages 3 to 17)
- Negative SARS-CoV-2 antigen rapid test at screening
- Negative pregnancy test for fertile females of reproductive age; not required for those not reached puberty or unable to have children
- Consent to use reliable contraception methods during the study for participants 14 to 55 years old with reproductive function
- Willingness to cooperate with study staff, attend visits, complete diaries, and follow protocol requirements
You will not qualify if you...
- Allergy to any component of the test or reference vaccine
- History of severe systemic reactions to any vaccines
- Unable to receive intramuscular injections
- Skin changes (pigmentation, tattoos, scars) at the injection site
- Acute infections or worsening chronic diseases within 14 days before screening
- Body temperature 37.0°C or higher at Visits 0 and 1
- Significant chronic diseases such as cancer, blood disorders, autoimmune diseases, or immunodeficiencies
- History of meningococcal infection
- Contact with confirmed meningococcal infection within 2 months before screening
- History of convulsive syndrome or advanced neurological disease
- History of Guillain-Barré syndrome
- History of mental illnesses
- Recent use of certain vaccines, immunostimulants, immunosuppressants, antipyretics, antibiotics, anticoagulants, or blood products within specified timeframes before visits
- Planned vaccination with other vaccines during the study
- Surgery within 3 months before screening
- Participation in another clinical study within 30 days before screening
- Other conditions judged by the investigator to interfere with enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with assessment at Day 29 ± 1
Participants receive one dose of either the GNG-DE vaccine or the reference Menactra® vaccine via intramuscular injection to help prevent meningococcal infection.
1 vaccination visit and 1 follow-up visit around Day 29
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
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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