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

PHASE3RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

February 12, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
InfectionsMeningococcal
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."

Trial Locations (17)

Unknown

COMPLETED

"Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of the Russian Federation", Kirov

RECRUITING

"Federal Budgetary Scientific Institution Central Research Institute of Epidemiology of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing", Moscow

COMPLETED

"Federal State Budgetary Scientific Institution I.I. Mechnikov Research Institute of Vaccines and Serums", Moscow

RECRUITING

"Federal State Budgetary Scientific Institution Russian Scientific Center of Surgery named after Academician B.V. Petrovsky", Moscow

RECRUITING

"State Budgetary Institution of Healthcare of the City of Moscow Morozovskaya Children's City Clinical Hospital of the Moscow City Healthcare Department", Moscow

COMPLETED

"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

RECRUITING

"State Budgetary Healthcare Institution of Perm Krai City Children's Clinical Polyclinic No. 5", Perm

COMPLETED

"Federal State Budgetary Institution A. A. Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation", Saint Petersburg

COMPLETED

"Federal State Budgetary Institution Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency", Saint Petersburg

RECRUITING

"Limited Liability Company Energy of Health", Saint Petersburg

RECRUITING

"Limited Liability Company PiterClinic", Saint Petersburg

RECRUITING

"Saint Petersburg State Budgetary Healthcare Institution Children's City Polyclinic No. 44", Saint Petersburg

RECRUITING

"Federal State Budgetary Educational Institution of Higher Education National Research Mordovian State University named after N.P. Ogarev", Saransk

RECRUITING

"Limited Liability Company DNA Research Center", Saratov

COMPLETED

"Limited Liability Company DNA Research Center", Saratov

RECRUITING

"Federal State Budgetary Educational Institution of Higher Education Smolensk State Medical University of the Ministry of Health of the Russian Federation", Smolensk

COMPLETED

"State Budgetary Healthcare Institution of the Sverdlovsk Region Central City Hospital No. 7, Yekaterinburg", Yekaterinburg

All Listed Sponsors
lead

NPO Petrovax

INDUSTRY