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This is part of an ongoing effort to develop a satisfactory dengue vaccine:
Primary objective:
To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates.
To describe the immune response after each vaccination of dengue vaccine.
Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
| |
| Group 3 | Experimental |
| |
| Group 4 | Experimental |
| |
| Group 5 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) | Biological | 0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine | 12 months post-vaccination |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tlalpan | 14050 | Mexico | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25483647 | Result | Dayan GH, Galan-Herrera JF, Forrat R, Zambrano B, Bouckenooghe A, Harenberg A, Guy B, Lang J. Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naive adults in Mexico. Hum Vaccin Immunother. 2014;10(10):2853-63. doi: 10.4161/21645515.2014.972131. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) | Biological | 0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105) |
|
| Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero) | Biological | 0.5 mL, Subcutaneous (SC) (Day 0 and Day 105) |
|
| Tetravalent CYD-1,2,3,4 Dengue (Vero) | Biological | 0.5 mL, Subcutaneous (SC) (Day 0 and Day 105) |
|
| JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero) | Biological | 0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105) |
|
|
| Valle de Chalco |
| 56613 |
| Mexico |
| ID | Term |
|---|---|
| D003715 | Dengue |
| D019595 | Severe Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
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