Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Live attenuated tetravalent dengue vaccine · 1 trial · 1 indication
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.
Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.
| Arm | Type | Description |
|---|---|---|
| DENGUE FORMULATION 17A GROUP | EXPERIMENTAL | Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6. |
| DENGUE FORMULATION 17B GROUP | EXPERIMENTAL | Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose. |
| DENGUE FORMULATION 19 GROUP | EXPERIMENTAL | Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose. |
| PLACEBO GROUP | PLACEBO_COMPARATOR | Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6. |
| Name | Type | Description |
|---|---|---|
| Live attenuated tetravalent dengue vaccine | BIOLOGICAL | Live attenuated tetravalent dengue vaccine |
| Placebo | BIOLOGICAL | Placebo |
Inclusion: * Healthy male or female adult 18-45 years at the time of vaccination * Free of obvious health problems as established by medical history and physical examination before entering into the study * Written informed consent obtained from the subject * Able to read the Subject Information Sh...
| 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 tetravalent dengue vaccine is an investigational vaccine being developed for the prevention of dengue. It is designed to target all four serotypes of the dengue virus. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
Live attenuated tetravalent dengue vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is currently in Phase 2 clinical development for the prevention of dengue.
Live attenuated tetravalent dengue vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The vaccine is being studied for the prevention of dengue, a mosquito-borne viral infection.
Live attenuated tetravalent dengue vaccine has one completed Phase 2 clinical trial, NCT00239577, which enrolled 86 healthy adults in the United States. The trial was a randomized, placebo-controlled study evaluating the vaccine's safety and immunogenicity in healthy US adults.
Live attenuated tetravalent dengue vaccine is a specific investigational vaccine candidate for dengue. It is designed to be tetravalent, meaning it targets all four serotypes of the dengue virus. It is currently in Phase 2 clinical development and is not yet approved.