Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

October 6, 2020

Primary Completion Date

December 8, 2020

Study Completion Date

December 8, 2020

Conditions
InfluenzaInfluenza, HumanInfluenza Viral InfectionsVaccine ReactionVaccination; Infection
Interventions
BIOLOGICAL

Influenza vaccine [inactivated]

Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine

BIOLOGICAL

Influenza vaccine [inactivated]

Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine

BIOLOGICAL

Influenza vaccine [inactivated]

Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine

Trial Locations (5)

Unknown

Federally Funded Healthcare Institution Primary Healthcare Unit No. 163,of Federal Medical and Biologic Agency (FFHI PHU No. 163, FMBA of Russia), Kol'tsovo

Bessalar Clinic. Clinical Trial Center Limited Liability Company (Bessalar Clinic. Clinical Trial Center LLC), Moscow

"Federation (FSBEI of Higher Education E. A. Wagner PSMU of the of the Ministry of Health of the Russian Federation)", Perm

Baltic Medicine Limited Liability Company (Baltic Medicine LLC), Saint Petersburg

Eco-Safety Scientific Research and Development Center Limited Liability Company (Eco-Safety Scientific Research and Development Center LLC), Saint Petersburg

All Listed Sponsors
lead

St. Petersburg Research Institute of Vaccines and Sera

OTHER_GOV

NCT05869201 - Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine | Biotech Hunter | Biotech Hunter