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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05572879

Enrollment

2600

Registered

2022-10-10

Start date

2022-10-01

Completion date

2024-02-09

Last updated

2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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

Interventions

BIOLOGICALEuCorVac-19

COVID-19 vaccine

BIOLOGICALChAdOx1 nCoV-19

COVID-19 vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026