Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine (NCT04691908) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine
Kazakhstan3,000 participantsStarted 2020-12-25
Plain-language 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
Who can participate
Age range18 Years – 100 Years
SexALL
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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 t…
What they're measuring
1
Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)
Timeframe: at days 0, 21, 42, 90, 180
2
To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo
Timeframe: at days 0, 21, 42, 90, 180
3
Frequency of confirmed cases of COVID-19
Timeframe: through study completion, an average of 6 months
Trial details
NCT IDNCT04691908
SponsorResearch Institute for Biological Safety Problems