A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572879
• Other study ID #: EuSNAP_COV301
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2022
• Est. completion date: February 9, 2024

Study information

• Verified date: November 2023
• Source: EuBiologics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2600
• Est. completion date: February 9, 2024
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• EuCorVac-19
COVID-19 vaccine
• ChAdOx1 nCoV-19
COVID-19 vaccine

Locations

Country	Name	City	State
Philippines	Trial site	Manila

Sponsors (1)

Lead Sponsor	Collaborator
EuBiologics Co.,Ltd

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1		14 days after the 2nd vaccination
Primary	The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1		14 days after the 2nd vaccination
Secondary	Occurrence of solicited Adverse Events (AEs)		Through 7 days after each vaccination
Secondary	Occurrence of unsolicited Adverse Events (AEs)		Through 28 days after the 2nd vaccination