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Also known as Tetravalent Dengue Vaccine (TDV)
Tetravalent Dengue Vaccine · 4 trials · 3 indications
GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 120 in the TDV (new) and TDV (current) groups will be reported.
GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were 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. Seropositivity is defined as reciprocal neutralizing titer ≥10.
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1.
| Arm | Type | Description |
|---|---|---|
| Tetravalent Dengue Vaccine (TDV) (New) | EXPERIMENTAL | Participants will receive TDV (new formulation) dose 1, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose). |
| Tetravalent Dengue Vaccine (TDV) (current) | EXPERIMENTAL | Participants will receive TDV (current approved formulation) 0.5 mL dose, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose). |
| Tetravalent Dengue Vaccine (TDV) | EXPERIMENTAL | TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose). |
| Placebo | PLACEBO_COMPARATOR | TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). |
| Tetravalent Dengue Vaccine (TDV) 0.5 mL | EXPERIMENTAL | Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study. |
| Name | Type | Description |
|---|---|---|
| Tetravalent Dengue Vaccine (TDV) | BIOLOGICAL | TDV subcutaneous injection |
| Placebo | BIOLOGICAL | Normal Saline (0.9% NaCl) subcutaneous injection |
Inclusion Criteria * Participant eligibility is determined according to the following criteria: * Participant is aged 18 to 60 years at the time of entry into the trial. * Participant is male or female. * Participant is in good health at the time of entry into the trial, as determined by medical hi...
| 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 |
Tetravalent Dengue Vaccine (TDV) is an investigational vaccine being studied for the prevention of dengue, dengue fever, and in healthy volunteers. It is designed to protect against the four serotypes of the dengue virus. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Tetravalent Dengue Vaccine is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is conducting multiple Phase 3 clinical trials to evaluate the vaccine's efficacy, safety, and immunogenicity in different populations, including children, adolescents, and adults.
Tetravalent Dengue Vaccine is in Phase 3 clinical development. Multiple Phase 3 trials are being conducted to assess its efficacy, safety, and immunogenicity. The vaccine is investigational and has not received regulatory approval. Clinical trials are ongoing or recently completed across various countries.
Tetravalent Dengue Vaccine has been studied in several Phase 3 trials, including NCT02747927 in healthy children, NCT03341637 in adolescents, NCT03771963 in healthy adults, and NCT07047521 in healthy adults. These trials evaluate efficacy, safety, and immunogenicity across different age groups and geographic regions.
Yes, Tetravalent Dengue Vaccine is also known as TDV. The abbreviation TDV is used in clinical trial titles and documentation. Researchers and healthcare professionals may refer to the vaccine by either name when discussing its development and study results.