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| Name | Class |
|---|---|
| Instituto Universitario IVI | OTHER |
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The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euvichol | Experimental |
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| Shanchol | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euvichol | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline | 14 days after second doses |
| Safety | Type and frequency of solicited adverse event type (Day 0 ~ 6), Type and frequency of unsolicited adverse event type (Day 0 ~ Day 28) | From first shot to 14 days after second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 1. Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O139 antibody, relative to baseline | 14 days after second doses |
| Safety | 1. Change from baseline in vital signs and physical examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto A. Espos, MD | De La Salle University Hospital Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antonio D. Ligsay, MD | Quezon City | 4332 | Philippines |
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| ID | Term |
|---|---|
| C000588783 | shanchol |
| D022121 | Cholera Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Shanchol | Biological |
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| From first shot to 14 days after second dose |
| Efficacy | 1. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by each anti-V. cholera antibody titer at Week 2 (Visit 3) after the second dose as compared to prior to investigational product dosing (Visit 1). | 14 days after second doses |
| Safety | 1. Change from baseline in laboratory tests (hematologic test, blood chemistry test, urinalysis) to be performed only in subjects who participate in the Pivotal study. | 14 days after second doses |