Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Live, attenuated, dengue serotype 1, 2, 3, 4 virus · 2 trials · 3 indications
Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \>=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction (RT-PCR) and/or dengue non-structural (NS) protein 1 antigen enzyme-linked immunosorbent assay (ELISA). Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.
Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature \>=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS protein 1 antigen enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.
| Arm | Type | Description |
|---|---|---|
| CYD Dengue Vaccine Group | EXPERIMENTAL | Participants were to receive 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months. |
| Placebo Group | PLACEBO_COMPARATOR | Participants were to receive a placebo vaccine at 0, 6, and 12 months. |
| Dengue Vaccine Group | EXPERIMENTAL | Participants were to receive CYD dengue vaccine at 0, 6, and 12 months. |
| Control Group | PLACEBO_COMPARATOR | Participants were to receive a placebo vaccine at 0, 6, and 12 months. |
| Name | Type | Description |
|---|---|---|
| Live, attenuated, dengue serotype 1, 2, 3, 4 virus | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Placebo: (NaCl) 0.9% solution | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Placebo: Sodium chloride (NaCl) 0.9% | BIOLOGICAL | 0.5 mL, Subcutaneous |
Inclusion Criteria: * Aged 9 to 16 years on the day of inclusion and resident of the site zone * Participant in good health, based on medical history and physical examination * Assent form or informed consent form has been signed and dated by the participant (based on local regulations), and inform...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 5 | PHASE3 | Tetravalent Dengue Vaccine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | EYU688 |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Undisclosed |
| Abbott Laboratories | ABT | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 1 | - | Undisclosed |
Live, attenuated, dengue serotype 1, 2, 3, 4 virus is an investigational vaccine being studied for the prevention of dengue and dengue fever. It is designed to protect against all four dengue virus serotypes. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Live, attenuated, dengue serotype 1, 2, 3, 4 virus is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting Phase 3 clinical trials to evaluate the vaccine's safety and efficacy in preventing dengue disease.
Live, attenuated, dengue serotype 1, 2, 3, 4 virus is in Phase 3 clinical development. Two large-scale Phase 3 trials have been completed, enrolling a total of over 20,000 healthy children and adolescents in Asia and Latin America. The vaccine remains investigational and has not received regulatory approval.
Live, attenuated, dengue serotype 1, 2, 3, 4 virus has been studied in two completed Phase 3 trials: NCT01373281, which enrolled 10,275 children aged 2 to 14 years in five Asian countries, and NCT01374516, which enrolled 20,869 children and adolescents aged 9 to 16 years in Latin America. Both trials were randomized, double-blind, and placebo-controlled.
Live, attenuated, dengue serotype 1, 2, 3, 4 virus is a tetravalent dengue vaccine candidate that contains live, attenuated versions of dengue virus serotypes 1, 2, 3, and 4. It is designed to provide immunity against all four serotypes of the dengue virus, which cause dengue fever and dengue hemorrhagic fever.