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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05572879
Recruitment Status : Active, not recruiting
First Posted : October 10, 2022
Last Update Posted : December 1, 2023
Sponsor:
Information provided by (Responsible Party):
EuBiologics Co.,Ltd

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: EuCorVac-19 Biological: ChAdOx1 nCoV-19 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : October 1, 2022
Actual Primary Completion Date : June 23, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: COVISHIELD


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1 [ Time Frame: 14 days after the 2nd vaccination ]
  2. The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1 [ Time Frame: 14 days after the 2nd vaccination ]

Secondary Outcome Measures :
  1. Occurrence of solicited Adverse Events (AEs) [ Time Frame: Through 7 days after each vaccination ]
  2. Occurrence of unsolicited Adverse Events (AEs) [ Time Frame: Through 28 days after the 2nd vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05572879


Locations
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Philippines
Trial site
Manila, Philippines
Sponsors and Collaborators
EuBiologics Co.,Ltd
More Information
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Responsible Party: EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier: NCT05572879    
Other Study ID Numbers: EuSNAP_COV301
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: December 1, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases