NCT04930003

Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine

Randomized, Blind, Placebo-controlled Phase- I Study and Randomized, Open Phase Phase-II Study of QazCoVac-P - COVID-19 Subunit 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 QazCoVac-P - COVID-19 Subunit 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 QazCoVac-P - COVID-19 Subunit vaccine when administered twice in healthy volunteers aged 18-50 years. Purpose of the Phase-II clinical study Evaluation of the safety and immunogenicity of QazCoVac-P - COVID-19 Subunit 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	QazCoVac-P -COVID-19 Subunit Vaccine	QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
OTHER	Placebo	The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)

Timeline

• Start date: 2021-06-15
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2021-06-18
• Last updated: 2023-12-07

Locations

1 site across 1 country: Kazakhstan