A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults
NCT ID: NCT05572879
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2600 participants
INTERVENTIONAL
2022-10-01
2024-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Test group(EuCorVac-19) - Cohort A
Cohort A - Immunogenicity cohort
EuCorVac-19
COVID-19 vaccine
Comparator group(ChAdOx1) - Cohort A
Cohort A - Immunogenicity cohort
ChAdOx1 nCoV-19
COVID-19 vaccine
Test group(EuCorVac-19) - Cohort B
Cohort B - Safety cohort
EuCorVac-19
COVID-19 vaccine
Comparator group(ChAdOx1) - Cohort B
Cohort B - Safety cohort
ChAdOx1 nCoV-19
COVID-19 vaccine
Interventions
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EuCorVac-19
COVID-19 vaccine
ChAdOx1 nCoV-19
COVID-19 vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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EuBiologics Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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Trial site
Manila, , Philippines
Countries
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References
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Lovell JF, Miura K, Baik YO, Lee C, Choi Y, Lee JY, Long CA, Ylade M, Lee-Llacer R, De Asis N, Trinidad-Aseron M, Manuel Ranola J, Zoleta De Jesus L, Her H. Year-Long Antibody Response to the EuCorVac-19 SARS-CoV-2 Vaccine in Healthy Filipinos. Vaccines (Basel). 2025 Jul 22;13(8):776. doi: 10.3390/vaccines13080776.
Lovell JF, Miura K, Baik YO, Lee C, Choi Y, Her H, Lee JY, Ylade M, Lee-Llacer R, De Asis N, Trinidad-Aseron M, Ranola JM, De Jesus LZ. Interim safety and immunogenicity analysis of the EuCorVac-19 COVID-19 vaccine in a Phase 3 randomized, observer-blind, immunobridging trial in the Philippines. J Med Virol. 2024 Sep;96(9):e29927. doi: 10.1002/jmv.29927.
Other Identifiers
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EuSNAP_COV301
Identifier Type: -
Identifier Source: org_study_id
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