Clinical trial NCT05603052: A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: EuBiologics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 2852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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
* 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

Primary outcomes:
measure: The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
timeFrame: 14 days after the 2nd vaccination
measure: The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1
timeFrame: 14 days after the 2nd vaccination
Secondary outcomes:
measure: Occurrence of solicited Adverse Events (AEs)
timeFrame: Through 7 days after each vaccination
measure: Occurrence of unsolicited Adverse Events (AEs)
timeFrame: Through 28 days after the 2nd vaccination
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Trial site
Study officials:
References: