COVID-19Phase 3NCT05603052
A Phase III of COVID-19 Vaccine EuCorVac-19 in Healthy Adults Aged 18 Years and Older
A Phase 3 study testing EuCorVac-19 and ChAdOx1 nCoV-19 in people with COVID-19, run by EuBiologics Co.,Ltd at 1 site in Democratic Republic of the Congo.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- EuCorVac-19 and ChAdOx1 nCoV-19
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,852 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 11 Jul 2022to 15 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Trial site
Kinshasa
About this study
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
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
- Conditions
- COVID-19
- Being tested
- EuCorVac-19, ChAdOx1 nCoV-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuCorVac-19Biological
COVID-19 vaccine
ChAdOx1 nCoV-19Biological
Also called COVISHIELD
COVID-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Test group(EuCorVac-19) - Cohort A | Experimental | Cohort A - Immunogenicity cohort Receives: Biological: EuCorVac-19 |
| Comparator group(ChAdOx1) - Cohort A | Active comparator | Cohort A - Immunogenicity cohort Receives: Biological: ChAdOx1 nCoV-19 |
| Test group(EuCorVac-19) - Cohort B | Experimental | Cohort B - Safety cohort Receives: Biological: EuCorVac-19 |
| Comparator group(ChAdOx1) - Cohort B | Active comparator | Cohort B - Safety cohort Receives: Biological: ChAdOx1 nCoV-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
Measured: 14 days after the 2nd vaccination
The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1
Measured: 14 days after the 2nd vaccination
Secondary outcomes (2)
Occurrence of solicited Adverse Events (AEs)
Measured: Through 7 days after each vaccination
Occurrence of unsolicited Adverse Events (AEs)
Measured: Through 28 days after the 2nd vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start11 Jul 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603052
- Sponsor's protocol ID
- EuSNAP_COV302
- Status last verified
- Jan 2025
- First submitted
- 1 Nov 2022
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05603052
- Acronym / sponsor ID
- EuSNAP_COV302
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,852 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test group(EuCorVac-19) - Cohort A | Experimental | Biological: EuCorVac-19Cohort A - Immunogenicity cohort |
| Comparator group(ChAdOx1) - Cohort A | Active comparator | Biological: ChAdOx1 nCoV-19Cohort A - Immunogenicity cohort |
| Test group(EuCorVac-19) - Cohort B | Experimental | Biological: EuCorVac-19Cohort B - Safety cohort |
| Comparator group(ChAdOx1) - Cohort B | Active comparator | Biological: ChAdOx1 nCoV-19Cohort B - Safety cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EuCorVac-19COVID-19 vaccine | Biological | Test group(EuCorVac-19) - Cohort A, Test group(EuCorVac-19) - Cohort B |
| ChAdOx1 nCoV-19Also: COVISHIELDCOVID-19 vaccine | Biological | Comparator group(ChAdOx1) - Cohort A, Comparator group(ChAdOx1) - Cohort B |
Primary outcome
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1
Time frame: 14 days after the 2nd vaccination
The difference in neutralizing antibody SRR of EuCorVac-19 and ChAdOx1
Time frame: 14 days after the 2nd vaccination
2 secondary outcomes
Occurrence of solicited Adverse Events (AEs)
Time frame: Through 7 days after each vaccination
Occurrence of unsolicited Adverse Events (AEs)
Time frame: Through 28 days after the 2nd vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EuCorVac-19 and ChAdOx1 nCoV-19 in people with COVID-19, run by EuBiologics Co.,Ltd at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of GMT of neutralizing antibody of EuCorVac-19 and ChAdOx1 (time frame: 14 days after the 2nd vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.