NCT05715918

Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 of Children at the Age of 12-17 Years Inclusive"

Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", of Children at the Age of 12-17 Years Inclusive"

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products · Other Government
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine for intramuscular injection	Volunteers ( Group 1 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
OTHER	Placebo comparator (without active ingredient) for intramuscular injection	Volunteers ( Group 2 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-12-01
• Completion: 2024-02-01
• First posted: 2023-02-08
• Last updated: 2023-03-07

Locations

4 sites across 1 country: Russia