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This is a Phase I/IIa Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVII in Healthy Adult Volunteers
Subjects will undergo a Screening period beginning up to 2 weeks prior to enrollment, the vaccinations will be administered on week 0 and week 3, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EG-COVII | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EG-COVII | Biological | EG-COVII is a bivalent vaccine to prevent SARS-CoV-2 infection against wild type and Omicron variants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of EG-COVII in healthy adult volunteers | Number of participants with adverse events (AEs) Number of participants with abnormal clinical laboratory results (hematology /chemistry /urinalysis) Number of participants with abnormal vital sign Number of participants with abnormal physical examination results | 7 weeks follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Chang, Dr. | Nucleus Network Pty Ltd- Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd- Melbourne | Melbourne | Victoria | 3004 | Australia |
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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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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |