Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", of childrens aged 12-17" (Clinical trials, phase III). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine of chidrens aged 12-17
Recruitment of volunteers will be competitive. A maximum of 450 children aged 12 to 17 years inclusive will be screened in the study, of which it is planned to include and randomize 300 children who meet the criteria for inclusion in the study and do not have non-inclusion criteria, data on which will be used for subsequent safety and immunogenicity analysis. Group 1 - 150 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly. Group 2 - 150 volunteers who will receive a placebo twice with an interval of 21 days intramuscularly. In case of withdrawal of volunteers from the study, their replacement is not provided.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
300
Volunteers ( Group 1 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
Volunteers ( Group 2 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
State Budgetary Health Institution of the Moscow Region "Elektrostal Central City Hospital"
Elektrostal, Moscow, Russia
Kirov Regional State Budgetary Health Institution "Kirov Regional Children's Clinical Hospital"
Kirov, Russia
FSBSI Chumakov FSC R&D IBP RAS
Moscow, Russia
St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District"
Saint Petersburg, Russia
Geometric mean titer (GMT)
The percentage of volunteers with an increase in geometric mean titer of specific antibodies (GMT) on day 21 after the second dose of vaccine / placebo in the virus neutralization test and ELISA.
Time frame: 21 days
Geometric mean titer (GMT)
The multiplicity of the increase in the geometric mean titer of specific antibodies (GMT) for 21 days after the second vaccination in the viral neutralization reaction and ELISA reaction.
Time frame: 21 days
The level of seroconversion
The level of seroconversion (titer of specific antibodies ≥ 4 times) on 21 days after the second vaccination in the reaction of virusneutralization and ELISA reaction
Time frame: 21 days
Geometric mean titer (GMT)
The mean geometric titer of specific antibodies (GMT) 12 and 24 weeks after the second vaccination in the viral neutralization reaction and ELISA reaction.
Time frame: 24 weeks
Geometric mean titer (GMT)
The multiplicity of the increase in the geometric mean titer of specific antibodies (GMT) 12 and 24 weeks after the second vaccination in the viral neutralization reaction and ELISA reaction.
Time frame: 24 weeks
The level of seroconversion
The level of seroconversion (titer of specific antibodies ≥ 4 times) 12 and 24 weeks after the second vaccination in the viral neutralization reaction and ELISA reaction.
Time frame: 24 weeks
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