A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older

EuBiologics

Status and phase: Completed; Phase 3

Conditions: COVID-19

Treatments: Biological: EuCorVac-19; Biological: ChAdOx1 nCoV-19

Study type: Interventional

Funder types: Industry

Identifiers

NCT05603052

EuSNAP_COV302

Details and patient eligibility

About

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

Enrollment: 2,852 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,852 participants in 4 patient groups

Test group(EuCorVac-19) - Cohort A

Experimental group

Description:

Cohort A - Immunogenicity cohort

Treatment:

Biological: EuCorVac-19

Comparator group(ChAdOx1) - Cohort A

Active Comparator group

Description:

Cohort A - Immunogenicity cohort

Treatment:

Biological: ChAdOx1 nCoV-19

Test group(EuCorVac-19) - Cohort B

Experimental group

Description:

Cohort B - Safety cohort

Treatment:

Biological: EuCorVac-19

Comparator group(ChAdOx1) - Cohort B

Active Comparator group

Description:

Cohort B - Safety cohort

Treatment:

Biological: ChAdOx1 nCoV-19