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Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug
Sponsor: NPO Petrovax
Summary
Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug
Official title: Simple Blinded Multicenter Randomized Comparative Study to Assess Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE
Key Details
Gender
All
Age Range
3 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-02-12
Completion Date
2025-12-31
Last Updated
2025-12-29
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (17)
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