Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

633

Participants

Timeline

Start Date

March 4, 2021

Primary Completion Date

July 30, 2021

Study Completion Date

September 6, 2021

Conditions
Influenza
Interventions
BIOLOGICAL

Flu-M Tetra [Inactivated split influenza vaccine] w/p

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Flu-M Tetra [Inactivated split influenza vaccine] w/o/p

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Ultrix [Inactivated split influenza vaccine]

solution for intramuscular injection, 0.5 ml

Trial Locations (11)

Unknown

"State Autonomous Health Institution Engels City Clinical Hospital No1", Engel's

Limited Liability Company Professorskaya Clinica, Perm

Limited Liability Company Energia Zdorovya, Saint Petersburg

Limited Liability Company MEDICINSKAYA CLINIKA, Saint Petersburg

Limited Liability Company Scientific Research Center Eco-Bezopasnost, Saint Petersburg

Piramida Limited Liability Company, Saint Petersburg

"Private Health Care Institution Clinical Hospital RZD-Medicine in Saint Petersburg", Saint Petersburg

"Saint Petersburg State Budgetary Healthcare Institution State Polyclinic No. 117", Saint Petersburg

"Saint Petersburg State Budgetary Healthcare Institution State Polyclinic No. 43", Saint Petersburg

"Limited Liability Company DNA Research Center", Saratov

"Federal State Budget Healthcare Institution Yaroslavl Region Clinical Hospital No. 2", Yaroslavl

All Listed Sponsors
lead

St. Petersburg Research Institute of Vaccines and Sera

OTHER_GOV

NCT05308212 - Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra | Biotech Hunter | Biotech Hunter