COVID-19
Conditions
Brief 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
Interventions
BIOLOGICALEuCorVac-19
COVID-19 vaccine
BIOLOGICALChAdOx1 nCoV-19
COVID-19 vaccine
Sponsors
EuBiologics Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1 | 14 days after the 2nd vaccination |
| The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1 | 14 days after the 2nd vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of solicited Adverse Events (AEs) | Through 7 days after each vaccination |
| Occurrence of unsolicited Adverse Events (AEs) | Through 28 days after the 2nd vaccination |
Countries
Democratic Republic of the Congo
Outcome results
None listed