NCT05572879CompletedPhase 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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- EuBiologics Co.,Ltd
- Enrollment
- 2,600
- Locations
- 1
- Primary Endpoint
- The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
Study Overview
Brief Summary
This is a phase III, randomized, observer-blind, active-controlled, parallel group, multi-center study to compare the immunogenicity and safety of a preventive COVID-19 vaccine EuCorVac-19 to ChAdOx1 in healthy adults aged 18 years and older
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Comparator group(ChAdOx1) - Cohort B
Active Comparator
Cohort B - Safety cohort
Intervention: ChAdOx1 nCoV-19 (Biological)
Test group(EuCorVac-19) - Cohort B
Experimental
Cohort B - Safety cohort
Intervention: EuCorVac-19 (Biological)
Comparator group(ChAdOx1) - Cohort A
Active Comparator
Cohort A - Immunogenicity cohort
Intervention: ChAdOx1 nCoV-19 (Biological)
Test group(EuCorVac-19) - Cohort A
Experimental
Cohort A - Immunogenicity cohort
Intervention: EuCorVac-19 (Biological)
Outcomes
Primary Outcomes
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
Time Frame: 14 days after the 2nd vaccination
The difference in neutralizing antibody SRR 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)
Investigators
Study Sites (1)
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