NCT05603052
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- EuCorVac-19
- Conditions
- COVID-19
- Sponsor
- EuBiologics Co.,Ltd
- Enrollment
- 2852
- Locations
- 1
- Primary Endpoint
- The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Test group(EuCorVac-19) - Cohort A
Cohort A - Immunogenicity cohort
Intervention: EuCorVac-19
Comparator group(ChAdOx1) - Cohort A
Cohort A - Immunogenicity cohort
Intervention: ChAdOx1 nCoV-19
Test group(EuCorVac-19) - Cohort B
Cohort B - Safety cohort
Intervention: EuCorVac-19
Comparator group(ChAdOx1) - Cohort B
Cohort B - Safety cohort
Intervention: ChAdOx1 nCoV-19
Outcomes
Primary Outcomes
The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1
Time Frame: 14 days after the 2nd vaccination
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
Time Frame: 14 days after the 2nd vaccination
Secondary Outcomes
- 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)
Study Sites (1)
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