Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group(EuCorVac-19) - Cohort A | Experimental | Cohort A - Immunogenicity cohort |
|
| Comparator group(ChAdOx1) - Cohort A | Active Comparator | Cohort A - Immunogenicity cohort |
|
| Test group(EuCorVac-19) - Cohort B | Experimental | Cohort B - Safety cohort |
|
| Comparator group(ChAdOx1) - Cohort B | Active Comparator | Cohort B - Safety cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EuCorVac-19 | Biological | COVID-19 vaccine |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trial site | Kinshasa | Democratic Republic of the Congo |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090985 | ChAdOx1 nCoV-19 |
| ID | Term |
|---|---|
| D019444 | Vaccines, DNA |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ChAdOx1 nCoV-19 | Biological | COVID-19 vaccine |
|
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |