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...
Top 2 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 5 | PHASE3 | Qdenga |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | EYU688 |
The tetravalent live attenuated dengue vaccine is an investigational vaccine developed by GSK plc (ticker: GSK) for the prevention of dengue. It is designed to protect against all four dengue virus serotypes. The vaccine is in Phase 1 clinical development and has been studied in a completed Phase I/II trial in Thailand.
The tetravalent live attenuated dengue vaccine is being developed for the prevention of dengue, an infectious disease caused by dengue virus. It is intended to induce immunity against all four dengue serotypes. The vaccine is investigational and has not been approved for use.
The tetravalent live attenuated dengue vaccine is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical development program for this vaccine candidate.
The tetravalent live attenuated dengue vaccine is in Phase 1 clinical development. It has completed one Phase I/II trial and is not yet approved for any indication. Further clinical testing would be required to establish its safety and efficacy.
The tetravalent live attenuated dengue vaccine has been studied in one completed clinical trial, NCT00322049. This was a Phase I/II trial in flavivirus antibody naive infants, conducted in Thailand, with 51 participants. The trial was randomized, double-blind, and active-controlled.