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Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT04691908•Research Institute for Biological Safety Problems

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Availability of signed and dated informed consent of the volunteer to participate in the study.
•Healthy male and female volunteers aged 18 and above. Ability and voluntary desire to independently keep records in the Self-Observation Diary, as well as to carry out all the repeated visits provided for in the study for control medical observation.
•The voluntary desire of females to use methods of reliable contraception throughout the entire period of their participation in the study.
•Negative results for IgM and IgG antibodies to SARS-CoV-2. Absence of COVID-19 diagnosis in history. Absence in the last 14 days of close contact with persons suspected of being infected with SARS-CoV-2, or persons whose diagnosis of COVID-19 has been confirmed with laboratory.

Exclusion Criteria

•Aggravated allergic history, drug intolerance, including hypersensitivity to any of the components of the study drug, as well as a history of serious adverse events during vaccine administration (such as allergic reactions, respiratory failure, angioedema, abdominal pain).
•Acute illness with a fever (body temperature ≥37.1 ° C) at the time of screening.
•History of chronic alcohol abuse and/or drug use. Positive results for antibodies IgM, IgG to SARS-CoV-2 Women with a positive urine pregnancy test. Simultaneous treatment with immunosuppressive drugs, incl. corticosteroids (2 weeks) 4 weeks prior to study drug administration.
•Acute or chronic clinically significant lesions of the lungs, cardiovascular system, gastrointestinal tract, liver, blood system, skin, endocrine, neurological and psychiatric diseases or impaired renal function (asthma, diabetes, thyroid disease, arrhythmia, heart attack myocardium, severe hypertension not controlled by drugs, etc.), identified based on the data of the medical history, physical examination, which, according to the researcher, may affect the study result.
•History of platelet disorder or other blood clotting disorders that may cause contraindications to intramuscular administration.
•History of leukemia or neoplasm. Persons with autoimmune diseases. A history of Guillain-Barré syndrome or other neuroimmunological diseases. Subjects who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to study drug administration; Subjects who received anti-inflammatory drugs 2 days prior to study drug administration; Participation in any other clinical research within the last 6 months. Subjects with regard to whom there is a concern that they will not comply with the requirements of the study, or persons with severe physical or mental disabilities that may affect the completion of the study.
•Voluntary refusal to study. Vulnerable research subjects.

Locations (1)

Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan

Gvardeyskiy, Jambul, Kazakhstan

Key Dates

Start Date

December 25, 2020

Primary Completion Date

April 26, 2021

Completion Date

July 11, 2021

Last Updated

December 13, 2023

Enrollment

3,000

ACTUAL participants

Conditions

Covid19SARS-CoV InfectionVaccine Adverse Reaction

Interventions

QazCovid-in®-vaccine against COVID-19

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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