This trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the IIIb-IV phase which was carried out in parallel groups of volunteers over the age of 60
The volunteers will include in the trial will divide into two groups: Group 1: volunteers who will receive one dose of Flu-M, solution for intramuscular injection, 0.5 mL, intramuscularly. Group 2: volunteers who will receive one dose of Ultrix®, solution for intramuscular administration, 0.5 mL, intramuscularly. The trial include the following periods and visits: 1. Screening period (up to 7 days): • Visit 0 (day -7...-1). 2. Vaccination period (up to 1 day): • Visit 1 (day 1, randomization, blood collection for serological examination, vaccination). 3. Follow-up period (up to 28(+2) days): * Visit 2 (day 3, organization of trials to assess safety); * Visit 3 (day 7(+1), organization of trials to assess safety); * Visit 4 (day 21(+2), organization of trials to assess safety, blood collection for serological study); * Visit 5 (day 28(+2), organization of trials to assess safety, trial completion);
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
320
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
LLC "Meditsinskie Tehnologii"
Saint Petersburg, Russia
LLC "Strategicheskie Meditsinskie Sistemi"
Saint Petersburg, Russia
Immunogenicity assessment
Seroconversion rate defined as the percentage of subjects who have a pre-vaccination titer of influenza haemagglutinin antibody titer (HA titer) \< 1:10 and a post-vaccination HA titer \>1:40 or a pre-vaccination HA titer \> 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline for each strain (A/H1N1, A/H3N2 and B)
Time frame: 21 days
The percentage of subjects with protective titer of antibodies ≥ 1:40 on the 21(+2) day after the vaccination for each strain (A/H1N1, A/H3N2 and B).
Time frame: 21 days
Increasing of geometric mean titer on the 21(+2) day against the value observed before the use of vaccine for each strain (A/H1N1, A/H3N2 and B)
Time frame: 21 days
The percentage of volunteers with a pre-vaccination HA titer <1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in a post-vaccination HA titer vs. the baseline should be > 30%
Time frame: 21 days
Increasing of geometric mean titer in > 2.0 times
Time frame: 21 days
The percentage with protective antibody titer ≥ 1:40
Time frame: 21 days
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