Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

PHASE3CompletedINTERVENTIONAL
Enrollment

1,066

Participants

Timeline

Start Date

February 16, 2021

Primary Completion Date

October 29, 2021

Study Completion Date

December 24, 2021

Conditions
Influenza, HumanVaccination; InfectionVaccines
Interventions
BIOLOGICAL

Flu-M, Inactivated split influenza vaccine 0.5 mL

Solution for intramuscular injection Сhildren were vaccinated with the Flu-M vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL

BIOLOGICAL

Vaxigrip, Inactivated split influenza vaccine 0.5 mL

Suspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine once/twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination; if the child is vaccinated for the first time) intramuscularly in a dose of 0.5 mL

BIOLOGICAL

Flu-M, Inactivated split influenza vaccine 0.25 mL

Solution for intramuscular injection Children were vaccinated with the Flu-M vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL

BIOLOGICAL

Vaxigrip, Inactivated split influenza vaccine 0.25 mL

Suspension for intramuscular and subcutaneous injection Children were vaccinated with the Vaxigrip® vaccine twice (all children were vaccinated twice with an interval of 28 days between the first vaccination and revaccination) intramuscularly in a dose of 0.25 mL

Trial Locations (2)

Unknown

"LLC Energiya zdorov'ya", Saint Petersburg

"St. Petersburg State Budgetary Institution of Health Care Children's City Polyclinic No. 45 of the Nevsky District", Saint Petersburg

All Listed Sponsors
lead

St. Petersburg Research Institute of Vaccines and Sera

OTHER_GOV

NCT05470582 - Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old | Biotech Hunter | Biotech Hunter