NCT04530357

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

Randomized, Blind, Placebo-controlled Phase- i Study and Randomized, Open Phase Phase-ii Study of QAZCOVID-IN®- COVID-19 Inactivated Vaccine in Healthy Adult Volunteers From 18 Years Old and Elder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Research Institute for Biological Safety Problems · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Randomized, blind, placebo-controlled phase- i study and randomized, open phase phase-ii study of QAZCOVID-IN®- COVID-19 inactivated vaccine in healthy adult volunteers from 18 years old and elder

Detailed description

Purpose of the Phase-I clinical study Evaluation of the safety,acceptability and immunogenicity of QazCovid-in®-COVID-19 inactivated vaccine when administeredtwice in healthy volunteers aged 18-50 years. Purpose of the Phase-II clinical study Evaluation of the safety and immunogenicity of QazCovid-in® - COVID-19 inactivated vaccine with single and dual use in healthy volunteers aged 18 and above.

Conditions

• Covid19
• SARS-CoV Infection
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	QazCovid-in® - COVID-19 inactivated vaccine	QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
OTHER	Placebo	Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)

Timeline

• Start date: 2020-09-19
• Primary completion: 2020-11-25
• Completion: 2021-04-25
• First posted: 2020-08-28
• Last updated: 2021-05-04

Locations

1 site across 1 country: Kazakhstan