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...
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 live attenuated tetravalent dengue vaccine is an investigational vaccine developed by GSK plc (ticker GSK) for the prevention of dengue. It is designed to protect against dengue, an infectious disease, and is being studied in healthy adult volunteers. It remains in clinical development and is not an approved product.
The live attenuated tetravalent dengue vaccine is being developed for the prevention of dengue, an infectious disease caused by dengue virus. Its clinical program has studied the vaccine in healthy adult volunteers aged 18 years and older. It is an investigational candidate and has not been approved for use.
GSK plc, which trades under the ticker GSK, is the developer of the live attenuated tetravalent dengue vaccine. The vaccine candidate is part of GSK's infectious disease pipeline and is directed at dengue prevention. The underlying clinical trial used a vaccine originally developed by the Walter Reed Army Institute of Research.
The live attenuated tetravalent dengue vaccine is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA or any other regulatory authority based on the available information.
The live attenuated tetravalent dengue vaccine has been studied in one completed Phase 2 trial, NCT00239577, titled a trial of a Walter Reed Army Institute of Research live attenuated virus tetravalent dengue vaccine in healthy US adults. The trial enrolled 86 participants in the United States, was randomized and placebo controlled, and included healthy volunteers aged 18 years and older.