Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01702857 | A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico) | PHASE1 | COMPLETED | 100 | — | — | Nov 1, 2012 | Mar 23, 2017 | May 23, 2017 | 1 | Puerto Rico |
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...