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Bivalent CYD-1, 3 Dengue+ Bivalent CYD-2, 4 Dengue · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| Group 3 | EXPERIMENTAL | - |
| Group 4 | EXPERIMENTAL | - |
| Group 5 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 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) |
| 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) |
Inclusion Criteria : * Healthy as determined by medical history, clinical examination, and biological safety parameters * Aged 18 to 45 years on the day of inclusion. * Informed consent form signed. * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of child...
Bivalent CYD-1,3 Dengue + Bivalent CYD-2,4 Dengue is an investigational monoclonal antibody combination developed by Sanofi for protection against dengue virus. It pairs two bivalent antibody components, one directed at dengue serotypes 1 and 3 and the other at serotypes 2 and 4, and has been studied in healthy flavivirus-naive adults.
It is being developed for the prevention of dengue virus infection, including dengue fever and dengue hemorrhagic fever. The clinical program has focused on healthy adult volunteers who have not previously been exposed to flaviviruses, evaluating safety and immune response against all four dengue serotypes.
Sanofi, which trades on the New York Stock Exchange under the ticker SNY, is the developer of Bivalent CYD-1,3 Dengue + Bivalent CYD-2,4 Dengue. The company has advanced the monoclonal antibody combination through Phase 2 clinical testing in dengue prevention.
Bivalent CYD-1,3 Dengue + Bivalent CYD-2,4 Dengue has reached Phase 2 development. It is investigational and has not been approved for marketing. The single Phase 2 trial in the program is completed, and no trials are currently listed as active.
The program includes one completed Phase 2 trial, NCT00740155, titled Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naive Adults. It enrolled 154 participants in Mexico, was randomized and actively controlled, and included adults 18 years and older of both sexes.