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

NCT05572879
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Phase
Phase 3
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Recruitment status
Completed
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Participants
2,600
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Lead sponsor
EuBiologics Co.,Ltd
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Start date
2022-10-01
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Number of sites
1
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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
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Short title
A Phase III Study of COVID-19 Vaccine EuCorVac-19 in Healthy Adults
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-02-09
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First posted
2022-10-10
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Registry last updated
2024-06-17
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Primary completion date
2023-06-23
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Start date
2022-10-01
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Actual participants
2,600
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Participants
2,600
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
EuBiologics Co.,Ltd
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05572879
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ClinicalTrials.gov ID
NCT05572879
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1

    Timeframe: 14 days after the 2nd vaccination

  2. The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1

    Timeframe: 14 days after the 2nd vaccination

  1. Occurrence of solicited Adverse Events (AEs)

    Timeframe: Through 7 days after each vaccination

  2. Occurrence of unsolicited Adverse Events (AEs)

    Timeframe: Through 28 days after the 2nd vaccination

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Trial siteManila, Philippines
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)