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

NCT04530357 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2021-05-04

No results posted yet for this study

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

Conditions

  • Covid19
  • SARS-CoV Infection
  • Vaccine Adverse Reaction

Interventions

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)

Sponsors & Collaborators

  • National Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan

    collaborator UNKNOWN

  • Research Institute for Biological Safety Problems

    lead OTHER_GOV

Principal Investigators

  • Berik Khairullin, PhD · Research Institute for Biological Safety Problems

  • Kunsulu Zakarya, PhD · Research Institute for Biological Safety Problems

  • Ilyas Kulmagambetov, PhD · Centre for Clinical Medicine and Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-19
Primary Completion
2020-11-25
Completion
2021-04-25

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530357 on ClinicalTrials.gov