Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tetravalent live attenuated dengue vaccine · 1 trial · 1 indication
Local and general solicited reactogenicity using diary cards for 21 days (days 0-20) after the first dose of dengue/control vaccine
Assess the immunogenicity of the dengue vaccine in terms of GMTs 30 days post-Dose 2 of dengue vaccine for all four serotypes (DEN-1, 2, 3, 4 and JE (Japanese encephalitis)). Analysis of immunogenicity was performed on the ATP cohort.
Seronegative for N antibody against DEN 1, 2, 3 and 4 antibody after dengue dose 2. Seronegative (antibody titer \<10 1/Dil for N lg to DEN-1, N lg to DEN-2, N lg to DEN-3, N lg) prior to vaccination.
Seropositivity for N antibody against DEN 1, 2, 3 and 4 antibody after dengue dose 2 (and 2 doses of JE). Seronegative (antibody titer \<10 1/Dil for N lg to DEN-1, N lg to DEN-2, N lg to DEN-3, N lg) prior to vaccination.
Seropositivity rates and GMTs for N lg to JEV antibodies. Pre= Pre vaccination, blood sampling prior to the first vaccine dose; PI(M1)= Post 1, month 1, blood sampling one month after dose 1 at study month 1; PI(M6)= Post 1, month 6, blood sampling 6 months after dose 1 at study month 6; PII(M7)= Post II, month 7, blood sampling one month after dose 2 at study month 7; PIV(M8.5)= Post IV, month 8.5, blood sampling after 2 doses of dengue/control and 2 doses of JE vaccines at study month 8.5
| Arm | Type | Description |
|---|---|---|
| Cohort A: Dengue Vaccine- Full Dose (T-DEN F17 ) | EXPERIMENTAL | Dengue vaccine at Months 0 and 6 and booster follow-up at 3 years; DEN candidate vaccine: One dose of the tetravalent, live attenuated DEN vaccine candidate, F17, contains dengue serotype 1, 2, 3 and 4 vaccines. This formulation contains 50 mcg/mL neomycin base, 5.5% lactose, and 1.9 g/dL human serum albumin; for subcutaneous injection. All infants subsequently received an inactivated JE vaccine approximately one and 1.5 months following dengue vaccine dose 2. The licensed JE vaccine in liquid form, was dosed at 0.25 ml for subcutaneous injection. |
| Cohort B: Control vaccines | ACTIVE_COMPARATOR | Control vaccines: Hemophilus influenza type b (Hib) vaccine and varicella vaccine |
| Cohort C: Dengue Vaccine - 1/10 Dose (T-DEN F17 ) | EXPERIMENTAL | Dengue vaccine at Months 0 and 6 and booster follow-up at 3 years |
| Name | Type | Description |
|---|---|---|
| Tetravalent live attenuated dengue vaccine | BIOLOGICAL | DEN candidate vaccine: One dose of the tetravalent, live attenuated DEN vaccine candidate, F17, contains dengue serotype 1, 2, 3 and 4 vaccines. This formulation contains 50 mcg/mL neomycin base, 5.5% lactose, and 1.9 g/dL human serum albumin; for subcutaneous injection. Infants received dengue vaccine at study months 0 and 6 or control vaccine (varicella vaccine at study month 0 and Haemophilus influenzae Type b Conjugate vaccine at study month 6). Both control vaccines are licensed for use in Thailand. All infants subsequently received an inactivated JE vaccine approximately one and 1.5 months following dengue vaccine dose 2. The licensed JE vaccine in liquid form, was dosed at 0.25 ml for subcutaneous injection. A booster dose of DEN vaccine was given to all subjects previously vaccinated with DEN vaccine in Dengue -001. The booster dose was administered approximately 42 months after dose 2 (at the Year 3 visit). |
| Varicella vaccine and Haemophilus influenzae Type b Conjugate vaccine | BIOLOGICAL | Infants received dengue vaccine at study months 0 and 6 or control vaccine (varicella vaccine at study month 0 and Haemophilus influenzae Type b Conjugate vaccine at study month 6). Both control vaccines are licensed for use in Thailand. |
Inclusion Criteria: * Male and female infants between 12 and 15 months (12 and \<16 months) of age at the time of the first dengue vaccination * Free of obvious health problems as established by medical history and clinical examination before entering into the study. As a marker of nutritional stat...
| 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 |
The tetravalent live attenuated dengue vaccine is an investigational vaccine being developed for the prevention of dengue, a mosquito-borne viral infection. It is designed to target all four dengue virus serotypes. The vaccine is currently in Phase 1 clinical development and has not been approved for use.
The tetravalent live attenuated dengue vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy volunteers.
The tetravalent live attenuated dengue vaccine is in Phase 1 clinical development. A Phase I/II trial has been completed, and the vaccine remains investigational. It has not received regulatory approval and is still being studied for its safety and immune response in participants.
The tetravalent live attenuated dengue vaccine has been studied in one completed clinical trial, NCT00322049, titled 'A Phase I/II Trial of Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Infants.' This randomized, double-blind, active-controlled trial enrolled 51 healthy infants aged 12 months in Thailand.
The tetravalent live attenuated dengue vaccine is a specific investigational vaccine candidate for dengue, designed to protect against all four serotypes of the dengue virus. It is not the same as other dengue vaccines that may be approved or in development, as it is a distinct product being developed by GSK.