Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
Takeda's Tetravalent Dengue Vaccine Candidate · 2 trials · 1 indication
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by microneutralization test \[MNT\].
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48.
| Arm | Type | Description |
|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | EXPERIMENTAL | High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\*10\^4 plaque forming units (PFU), 5\*10\^4 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively. |
| Tetravalent Dengue Vaccine (TDV) | EXPERIMENTAL | Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\*10\^4 plaque forming units (PFU), 5\*10\^3 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively. |
| Group 1 (TDV 2-Dose) | EXPERIMENTAL | Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Day 365. |
| Group 2 (TDV 1-Dose) | EXPERIMENTAL | Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Day 1. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Days 91 and 365. |
| Group 3 (TDV 1-Dose + Booster) | EXPERIMENTAL | Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Day 91. |
| Group 4 (Placebo Control) | PLACEBO_COMPARATOR | Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Days 1, 91 and 365. |
| Name | Type | Description |
|---|---|---|
| Takeda's Tetravalent Dengue Vaccine Candidate (TDV) | BIOLOGICAL | TDV subcutaneous injection |
| Takeda's High-Dose Tetravalent Dengue Vaccine Candidate (HD-TDV) | BIOLOGICAL | High-dose TDV subcutaneous injection |
| TDV Placebo | BIOLOGICAL | Placebo-matching vaccine |
Inclusion Criteria: 1. Participant signs and dates a written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements. 2. Is aged 21 to ...
Takeda's Tetravalent Dengue Vaccine Candidate is being developed for the prevention of dengue fever, an infectious disease. It is a vaccine designed to induce immune responses against dengue. The candidate has been studied in Phase 2 clinical trials in healthy volunteers, including adults and children, in several countries.
Takeda's Tetravalent Dengue Vaccine Candidate is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sole developer of this vaccine candidate for dengue fever.
Takeda's Tetravalent Dengue Vaccine Candidate is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no active trials are currently listed. The candidate is investigational and has not been approved by the FDA for any indication.
Takeda's Tetravalent Dengue Vaccine Candidate has been evaluated in two completed Phase 2 trials. NCT02425098 studied two different serotype 2 potencies in 351 adults in Singapore. NCT02302066 studied different vaccination schedules in 1,800 healthy participants in the Dominican Republic, Panama, and the Philippines. Both trials were randomized, double-blind, and controlled.
Yes, Takeda's Tetravalent Dengue Vaccine Candidate is also known as TDV. TDV is the abbreviated name used in trial titles and scientific literature for the same vaccine candidate developed by Takeda Pharmaceutical Company Limited for dengue fever.