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Recruiting
NCT05603052
A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older
Conditions: COVID-19
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 4000
Sponsor: EuBiologics Co.,Ltd
Location: Congo, The Democratic Republic of the
Summary
A phase III, randomized, observer-blind, active-controlled, parallel-group, multi-center study to evaluate immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 in healthy adults aged 18 years and older
Eligibility Criteria
Inclusion Criteria:Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consentFemale of childbearing potential who agree to use medically allowed methods of contraception during the study periodIndividuals who agrees not to perform blood donation and transfusion during the study periodExclusion Criteria:Individual being considered to be confirmed COVID-19Direct contact with COVID-19 infected person within 14 days prior to the 1st dose of the IPIndividuals at high risk of exposure to SARS-CoV-2Individuals with clinically significant abnormalities in clinical laboratory tests, ECGs, and chest X-ray during screeningIndividuals with fever within 72 hours prior to the 1st dose of the IP or suspected other infectious disease or symptoms associated with other infectious diseaseIndividuals with serious medical or psychiatric diseaseHistory of SARS-CoV or MERS-CoV infectionHistory of allergic reaction or hypersensitivity reactions to any of components of the IPHistory of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccinationHistory of receiving organ or bone marrow transplantSuspected or history of drug abuse or alcohol abuse within 6 months prior to vaccinationHistory of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2History of vaccination with test vaccine substanceTreatment with immunosuppressants or immune modifying drugsHistory of treatment with antipsychotics or opioid dependencePregnant or lactating womenOther reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
Source: ClinicalTrials.gov (NCT05603052). StuddyBuddy aggregates publicly available trial information.