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

EuSNAP_COV302

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

2022-07-11

2024-06-30

2024-12-31

Recruiting

Early phase I

4000

Inclusion Criteria: * Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent * Female of childbearing potential who agree to use medically allowed methods of contraception during the study period * Individuals who agrees not to perform blood donation and transfusion during the study period Exclusion Criteria: * Individual being considered to be confirmed COVID-19 * Direct contact with COVID-19 infected person within 14 days prior to the 1st dose of the IP * Individuals at high risk of exposure to SARS-CoV-2 * Individuals with clinically significant abnormalities in clinical laboratory tests, ECGs, and chest X-ray during screening * Individuals with fever within 72 hours prior to the 1st dose of the IP or suspected other infectious disease or symptoms associated with other infectious disease * Individuals with serious medical or psychiatric disease * History of SARS-CoV or MERS-CoV infection * History of allergic reaction or hypersensitivity reactions to any of components of the IP * History of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination * History of receiving organ or bone marrow transplant * Suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination * History of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2 * History of vaccination with test vaccine substance * Treatment with immunosuppressants or immune modifying drugs * History of treatment with antipsychotics or opioid dependence * Pregnant or lactating women * Other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 4000, 'type': 'ESTIMATED'}}

2024-01-17