The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers
The maximum period of the volunteers' participation in the trial will be 35 ± 2 days. Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period - 28±2 days. All volunteers are followed by a clinical investigator for 6 months after vaccination outside of this trial with the aim of detecting possible late adverse reactions. If a volunteer has any delayed-type reactions, the volunteer will be invited to the clinic for correction of his/her condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
75
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
Federally Funded Healthcare Institution Primary Healthcare Unit No. 163
Novosibirsk, Russia
Incidence of adverse events (local and systemic post-vaccination reactions)
Time frame: days 1-7
Incidence of adverse events (systemic post-vaccination reactions)
Time frame: days 1-7
Incidence of any serious adverse events during the trial
Time frame: days 1-28
The content of specific anti-influenza antibodies in serum
Time frame: days 0, 28 after the vaccination
The geometric mean titer (GMT) of antibodies to hemagglutinins of the influenza virus
Time frame: days 0, 28 after the vaccination
Seroconversion factor
It shout be more than 2.5 after the vaccination
Time frame: days 0, 28
Seroconversion level
Time frame: days 0, 28 after the vaccination
Seroprotection level
Time frame: days 0, 28 after the vaccination
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