A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: EuCorVac-19
* Biological: ChAdOx1 nCoV-19


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group(EuCorVac-19) - Cohort A<br>Cohort A - Immunogenicity cohort | Biological: EuCorVac-19<br>* COVID-19 vaccine<br>|
| Active Comparator: Comparator group(ChAdOx1) - Cohort A<br>Cohort A - Immunogenicity cohort | Biological: ChAdOx1 nCoV-19<br>* COVID-19 vaccine<br>* Other names: COVISHIELD;|
| Experimental: Test group(EuCorVac-19) - Cohort B<br>Cohort B - Safety cohort | Biological: EuCorVac-19<br>* COVID-19 vaccine<br>|
| Active Comparator: Comparator group(ChAdOx1) - Cohort B<br>Cohort B - Safety cohort | Biological: ChAdOx1 nCoV-19<br>* COVID-19 vaccine<br>* Other names: COVISHIELD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |