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
Not Provided
Biological: EuCorVac-19
COVID-19 vaccine
Biological: ChAdOx1 nCoV-19
COVID-19 vaccine
Other Name: COVISHIELD
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
Trial site
Kinshasa, Congo, The Democratic Republic of the
Collin Choi
+82-2-572-6675
collin.choi@eubiologics.com
Not Provided