A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults
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
1 other identifier
interventional
2,600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Oct 2022
Typical duration for phase_3 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2024
CompletedJune 17, 2024
November 1, 2023
9 months
October 6, 2022
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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 Arms (4)
Test group(EuCorVac-19) - Cohort A
EXPERIMENTALCohort A - Immunogenicity cohort
Comparator group(ChAdOx1) - Cohort A
ACTIVE COMPARATORCohort A - Immunogenicity cohort
Test group(EuCorVac-19) - Cohort B
EXPERIMENTALCohort B - Safety cohort
Comparator group(ChAdOx1) - Cohort B
ACTIVE COMPARATORCohort B - Safety cohort
Interventions
COVID-19 vaccine
COVID-19 vaccine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Trial site
Manila, Philippines
Related Publications (2)
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.
PMID: 40872863DERIVEDLovell 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.
PMID: 39318203DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 10, 2022
Study Start
October 1, 2022
Primary Completion
June 23, 2023
Study Completion
February 9, 2024
Last Updated
June 17, 2024
Record last verified: 2023-11