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RECRUITING
NCT06834100
PHASE3

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

Sponsor: NPO Petrovax

View on ClinicalTrials.gov

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

Interventions

DRUG

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