Comparative assessment of the tolerability, safety and immunogenicity of the Flu-M vaccine vs. the Ultrix® vaccine by single vaccination of children aged 6 to 17 years.
At Stage I of the trial, it is planned to screen not more than 350 children aged 12 to 17 years (12 years 0 months 0 days - 17 years 11 months 30 days), of which it is planned to include and randomize 300 children meeting the inclusion and non-inclusion criteria. Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Ultrix® vaccine in the first 7 days after the vaccination of volunteers, during Phase I, an "Opinion on Tolerability and Safety Assessment for the Flu-M Vaccine vs. the Ultrix® Vaccine Involving Children Aged 12-17 Years (12 Years 0 Months 0 Days - 17 Years 11 Months 30 Days) will be prepared/ During Phase II , the trial for Phase I volunteers will continue in full in accordance with the Clinical Trial Regulations. During the trial, not more than 350 children aged between 6 - 11 years (6 years 0 months - 0 days - 11 years 11 months 30 days) will be further screened, of which it is planned to include and randomize 300 children meeting the inclusion criteria and not falling under the non-inclusion criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
600
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
Perm State Medical University named after Academician E. A. Wagner
Perm, Russia
LLC "Meditsinskie Tehnologii"
Saint Petersburg, Russia
Change from Baseline Geometric mean antibodies titer (GMT) at 28 days
Time frame: Days 0-28
Change from Baseline Seroconversion rate at 28 days
An increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise. Seroconversion level ≥ 40%.
Time frame: Days 0-28
Change from Baseline Seroprotection rate at 28 days
The percentage of subjects with a generated protective influenza haemagglutinin antibody titer (HA titer) (at least 1:40) vs. the baseline level. Seroprotection level ≥ 70%.
Time frame: Days 0-28
Change from Baseline Seroconversion factor at 28 days
The percentage of subjects who have a prevaccination titer of HA titer \<1:10 and a post-vaccination HA titer \>1:40 OR a prevaccination HA titer \> 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline. Seroconversion factor ≥ 2.5.
Time frame: Days 0-28
Immediate adverse events
Allergic reactions that revaccination and are reported either by a volunteer / volunteer's parents to the clinical investigator
Time frame: During 2 hours after vaccination
Adverse events
Local or systemic reactions that are reported either by a clinical investigator or by a volunteer / vaccinated volunteer's parents by phone
Time frame: During 7 days after vaccination
Incidence of severe adverse events during the trial
Time frame: Measurements will be taken then up to 28 days post-vaccination
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