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
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

Detailed Description

Not Provided

Recruiting
COVID-19

Biological: EuCorVac-19

COVID-19 vaccine

Biological: ChAdOx1 nCoV-19

COVID-19 vaccine
Other Name: COVISHIELD

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Congo, The Democratic Republic of the
Locations

Trial site
Kinshasa, Congo, The Democratic Republic of the

Contacts

Collin Choi
+82-2-572-6675
collin.choi@eubiologics.com

Not Provided

EuBiologics Co.,Ltd
NCT Number
MeSH Terms
COVID-19