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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
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trial site | Manila | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40872863 | Derived | 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. | |
| 39318203 | Derived |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090985 | ChAdOx1 nCoV-19 |
| ID | Term |
|---|---|
| D019444 | Vaccines, DNA |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
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| ChAdOx1 nCoV-19 | Biological | COVID-19 vaccine |
|
|
| 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. |
| 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 |