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

January 14, 2024 updated by: EuBiologics Co.,Ltd

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group(EuCorVac-19) - Cohort A
Cohort A - Immunogenicity cohort
Biological: EuCorVac-19
COVID-19 vaccine
Active Comparator: Comparator group(ChAdOx1) - Cohort A
Cohort A - Immunogenicity cohort
Biological: ChAdOx1 nCoV-19
COVID-19 vaccine
Other Names:
  • COVISHIELD
Experimental: Test group(EuCorVac-19) - Cohort B
Cohort B - Safety cohort
Biological: EuCorVac-19
COVID-19 vaccine
Active Comparator: Comparator group(ChAdOx1) - Cohort B
Cohort B - Safety cohort
Biological: ChAdOx1 nCoV-19
COVID-19 vaccine
Other Names:
  • COVISHIELD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
Time Frame: 14 days after the 2nd vaccination
14 days after the 2nd vaccination
The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1
Time Frame: 14 days after the 2nd vaccination
14 days after the 2nd vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of solicited Adverse Events (AEs)
Time Frame: Through 7 days after each vaccination
Through 7 days after each vaccination
Occurrence of unsolicited Adverse Events (AEs)
Time Frame: Through 28 days after the 2nd vaccination
Through 28 days after the 2nd vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EuBiologics Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 14, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuSNAP_COV302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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