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

NCT ID: NCT05572879

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-02-09

Brief Summary

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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

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test group(EuCorVac-19) - Cohort A

Cohort A - Immunogenicity cohort

Group Type EXPERIMENTAL

EuCorVac-19

Intervention Type BIOLOGICAL

COVID-19 vaccine

Comparator group(ChAdOx1) - Cohort A

Cohort A - Immunogenicity cohort

Group Type ACTIVE_COMPARATOR

ChAdOx1 nCoV-19

Intervention Type BIOLOGICAL

COVID-19 vaccine

Test group(EuCorVac-19) - Cohort B

Cohort B - Safety cohort

Group Type EXPERIMENTAL

EuCorVac-19

Intervention Type BIOLOGICAL

COVID-19 vaccine

Comparator group(ChAdOx1) - Cohort B

Cohort B - Safety cohort

Group Type ACTIVE_COMPARATOR

ChAdOx1 nCoV-19

Intervention Type BIOLOGICAL

COVID-19 vaccine

Interventions

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EuCorVac-19

COVID-19 vaccine

Intervention Type BIOLOGICAL

ChAdOx1 nCoV-19

COVID-19 vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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COVISHIELD

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EuBiologics Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Trial site

Manila, , Philippines

Site Status

Countries

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Philippines

References

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Lovell JF, Miura K, Baik YO, Lee C, Choi Y, Lee JY, Long CA, Ylade M, Lee-Llacer R, De Asis N, Trinidad-Aseron M, Manuel Ranola J, Zoleta De Jesus L, Her H. Year-Long Antibody Response to the EuCorVac-19 SARS-CoV-2 Vaccine in Healthy Filipinos. Vaccines (Basel). 2025 Jul 22;13(8):776. doi: 10.3390/vaccines13080776.

Reference Type DERIVED
PMID: 40872863 (View on PubMed)

Lovell JF, Miura K, Baik YO, Lee C, Choi Y, Her H, Lee JY, Ylade M, Lee-Llacer R, De Asis N, Trinidad-Aseron M, Ranola JM, De Jesus LZ. Interim safety and immunogenicity analysis of the EuCorVac-19 COVID-19 vaccine in a Phase 3 randomized, observer-blind, immunobridging trial in the Philippines. J Med Virol. 2024 Sep;96(9):e29927. doi: 10.1002/jmv.29927.

Reference Type DERIVED
PMID: 39318203 (View on PubMed)

Other Identifiers

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EuSNAP_COV301

Identifier Type: -

Identifier Source: org_study_id

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