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CompletedNCT05603052Updated Jan 7, 2025

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

A Phase 3 interventional study of EuCorVac-19 and ChAdOx1 nCoV-19 in COVID-19, sponsored by EuBiologics Co.,Ltd. Completed at 1 site in Congo, The Democratic Republic of the. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by EuBiologics Co.,Ltd · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2022, registered Nov 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
2,852
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 2,852 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

EuBiologics Co.,Ltd is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 18 years and older who voluntarily decide to participate in this study and provide written
  • Female of who agree to use medically allowed methods of during the study period
  • Individuals who agrees not to perform blood donation and transfusion during the study period

Exclusion criteria

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 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 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 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,852 participants (actual)

Study arms

  • Experimental
    Test group(EuCorVac-19) - Cohort A

    Cohort A - Immunogenicity cohort

    Biological: EuCorVac-19

  • Active comparator
    Comparator group(ChAdOx1) - Cohort A

    Cohort A - Immunogenicity cohort

    Biological: ChAdOx1 nCoV-19

  • Experimental
    Test group(EuCorVac-19) - Cohort B

    Cohort B - Safety cohort

    Biological: EuCorVac-19

  • Active comparator
    Comparator group(ChAdOx1) - Cohort B

    Cohort B - Safety cohort

    Biological: ChAdOx1 nCoV-19

Interventions

  • BiologicalEuCorVac-19

    COVID-19 vaccine

  • BiologicalChAdOx1 nCoV-19

    COVID-19 vaccine

    Also known as: COVISHIELD

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Trial site
    Kinshasa, Congo, The Democratic Republic of the
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05603052
Lead sponsor
EuBiologics Co.,Ltd
Responsible party
Sponsor
First posted
Nov 2, 2022
Start date
Jul 11, 2022
Primary completion
Jan 15, 2024
Completion
Jan 15, 2024
Last update
Jan 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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