NCT04691908

Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine

Multicenter, Randomized, Blind, Placebo-controlled Clinical Study of III Phase on Assessment of Preventive Efficiency, Safety and Immunogenicity QazCovid-in®-Vaccine Against COVID-19 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,000 (actual)
• Sponsor: Research Institute for Biological Safety Problems · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers

Detailed description

The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher increase in antibody titers to SARS-CoV-2) on the 21st, 42nd day, 90th and 180th days after vaccination. To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo. Evaluate vaccine efficacy. Evaluate the safety of vaccine versus placebo.

Conditions

• Covid19
• SARS-CoV Infection
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	QazCovid-in®-vaccine against COVID-19	QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
OTHER	Placebo	Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)

Timeline

• Start date: 2020-12-25
• Primary completion: 2021-04-26
• Completion: 2021-07-11
• First posted: 2020-12-31
• Last updated: 2023-12-13

Locations

1 site across 1 country: Kazakhstan