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...
It is an investigational vaccine candidate being developed by GSK plc for the prevention of dengue fever. The formulation combines a tetravalent dengue virus purified inactivated vaccine with an alum adjuvant, and it has been studied in a Phase 1 clinical trial in healthy adults.
It is being developed for the prevention of dengue fever, an infectious disease caused by dengue virus. The candidate is intended for use as a two-dose primary vaccination in healthy adults. It remains investigational and has not been approved for commercial use.
GSK plc, which trades under the ticker GSK, is the developer of this vaccine candidate. The company sponsored the Phase 1 study of the tetravalent dengue virus purified inactivated vaccine with alum adjuvant conducted in Puerto Rico.
It is in Phase 1 clinical development. The single Phase 1 trial of this candidate has been completed, and the vaccine remains investigational. No later-stage trials or regulatory approvals have been reported for this formulation.
The candidate was evaluated in one Phase 1 trial, NCT01702857, titled a two-dose primary vaccination study of a tetravalent dengue virus purified inactivated vaccine versus placebo in healthy adults in Puerto Rico. The trial enrolled 100 participants, was randomized, double-blind, and placebo-controlled, and is completed.