Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
45
Perm State Medical University named after academician E.A. Wagner
Perm, Russia
Severity of reported local reactions and their relationship with the vaccination
Time frame: days 1-7
Severity of reported system reactions and their relationship with the vaccination - during 7 days after the vaccination (the day of vaccination and 6 subsequent days)
Time frame: days 1-7
Severity of local reactions reported by participants of the study and their relationship with the vaccination
Time frame: days 8-20
Severity of system reactions reported by participants of the study and their relationship with the vaccination
Time frame: days 8-20
The measurement physical data at each visit of the trial site by the volunteer
Time frame: days 1-20
The immunogenicity assessment of the vaccine was carried out by the seroconversion factor
Time frame: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by Geometric mean titer
Time frame: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by seroprotection levels
Time frame: Measurements will be taken at screening, then up to 21 days post-vaccination
The immunogenicity assessment of the vaccine was carried out by seroconversion
Time frame: Measurements will be taken at screening, then up to 21 days post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.