A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Test group(EuCorVac-19) - Cohort A Cohort A - Immunogenicity cohort |
Biological: EuCorVac-19
COVID-19 vaccine
|
Active Comparator: Comparator group(ChAdOx1) - Cohort A Cohort A - Immunogenicity cohort |
Biological: ChAdOx1
COVID-19 vaccine
|
Experimental: Test group(EuCorVac-19) - Cohort B Cohort B - Safety cohort |
Biological: EuCorVac-19
COVID-19 vaccine
|
Active Comparator: Comparator group(ChAdOx1) - Cohort B Cohort B - Safety cohort |
Biological: ChAdOx1
COVID-19 vaccine
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
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
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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
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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
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History of vaccination against SARS-CoV, MERS-CoV, or SARS-CoV-2
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History of vaccination with test vaccine substance
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Trial site | Manila | Philippines |
Sponsors and Collaborators
- EuBiologics Co.,Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EuSNAP_COV301