NCT05297994

Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA

Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA vs. the Vaxigrip® Inactivated Influenza Split Vaccine Manufactured by Sanofi Pasteur, France, in Volunteers Aged 18-60 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split influenza vaccine in volunteers aged 18-60 years

Detailed description

All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flu-M [Inactivated split influenza vaccine]	solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Inactivated influenza split vaccine	solution for intramuscular injection, 0.5 ml

Timeline

• Start date: 2016-10-24
• Primary completion: 2016-12-12
• Completion: 2017-03-09
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

3 sites across 1 country: Russia