Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1 µg TDENV-PIV with Alum adjuvant · 1 trial · 1 indication
Safety and Reactogenicity: * Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) during the 7-day follow-up period post each vaccination (Day 0-6) * Occurrence, intensity and relationship to vaccination of unsolicited AEs during the 28-day follow-up period post each vaccination (Day 0-27) * Hematological and biochemical levels at study visits on Days 0, 7, 28, 35 and 56 * Occurrence of serious adverse events (SAEs) from Day 0 to Day 56 * Occurrence of potential immune-mediated diseases (pIMDs) and medically attended AEs from Day 0 to Day 56
Humoral Immunogenicity: Neutralizing antibody titers specific to each DENV type at Day 56 * Geometric mean titers (GMTs) of neutralizing antibody titers to each DENV type * Rate of fold increases in neutralizing antibody from Day 0 for each DENV type * Seropositivity rates for each DENV type * Trivalent and tetravalent seropositivity rates
| Arm | Type | Description |
|---|---|---|
| TDENV-PIV alum4 | EXPERIMENTAL | 4 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days |
| TDENV-PIV AS03B | EXPERIMENTAL | 1 µg TDENV-PIV with AS03B adjuvant; 0.5 mL intramuscular injection at 0 and 28 days |
| Placebo | PLACEBO_COMPARATOR | Phosphate buffered saline; 0.5 mL intramuscular injection at 0 and 28 days |
| TDENV-PIV alum1 | EXPERIMENTAL | 1 µg TDENV-PIV with Alum adjuvant; 0.5 mL intramuscular injection at 0 and 28 days |
| TDENV-PIV AS01E | EXPERIMENTAL | 1 µg TDENV-PIV with AS01E adjuvant; 0.5 mL intramuscular injection at 0 and 28 days |
| Name | Type | Description |
|---|---|---|
| Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant | BIOLOGICAL | - |
| Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant | BIOLOGICAL | - |
| Phosphate buffered saline | OTHER | - |
| 1 µg TDENV-PIV with Alum adjuvant | BIOLOGICAL | - |
| 1 µg TDENV-PIV with AS01E adjuvant | BIOLOGICAL | - |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, etc.) * A male or female between 20 and 39 years of age (inclusive) at the time of consent * Written informed con...
1 µg TDENV-PIV with Alum adjuvant is an investigational vaccine being studied for the prevention of Dengue Fever. It is a tetravalent dengue virus purified inactivated vaccine, meaning it is designed to protect against the four serotypes of the dengue virus. The vaccine is currently in clinical development and is not yet approved for public use.
1 µg TDENV-PIV with Alum adjuvant is being developed by GSK plc, a global biopharma company traded on the New York Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and immunogenicity of this investigational dengue vaccine candidate.
1 µg TDENV-PIV with Alum adjuvant is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine is still in the early stages of clinical testing for Dengue Fever.
1 µg TDENV-PIV with Alum adjuvant has one completed Phase 1 clinical trial, registered as NCT01702857. This was a two-dose primary vaccination study comparing the vaccine to placebo in 100 healthy adults in Puerto Rico. The trial was randomized, double-blind, and placebo-controlled, and it enrolled participants aged 20 years and older.
Yes, 1 µg TDENV-PIV with Alum adjuvant is a tetravalent dengue virus purified inactivated vaccine. The term tetravalent means it targets all four serotypes of the dengue virus. The vaccine includes an alum adjuvant, which is added to enhance the immune response. This formulation is being evaluated in clinical trials for Dengue Fever.