Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women

PHASE3CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

January 23, 2020

Primary Completion Date

March 11, 2021

Study Completion Date

July 26, 2021

Conditions
Influenza, HumanVaccination; InfectionVaccines
Interventions
BIOLOGICAL

Flu-M, Inactivated split influenza vaccine

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Ultrix®, Inactivated Split Influenza Vaccine

solution for intramuscular injection, 0.5 ml

Trial Locations (5)

Unknown

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

"Federal State Budgetary Institution Siberian Federal Scientific and Clinical Center of Federal Medical and Biologic Agency", Seversk

"Curator Limited Liability Company", Saint Petersburg

KOROLEV MEDICINE Limited Liability Company, Saint Petersburg

"Municipal Budgetary Institution Central City Hospital No.7", Yekaterinburg

All Listed Sponsors
lead

St. Petersburg Research Institute of Vaccines and Sera

OTHER_GOV

NCT05457894 - Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women | Biotech Hunter | Biotech Hunter