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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01830855 | A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years | PHASE3 | COMPLETED | 3,596 | — | — | Apr 1, 2013 | Apr 1, 2015 | Jun 14, 2016 | 99 | United States, Canada +6 |
| NCT01323270 | A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years. | PHASE2 | COMPLETED | 753 | — | — | Mar 18, 2011 | Feb 19, 2013 | Oct 27, 2022 | 36 | Finland, Germany +1 |
Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.
Here, N signifies participants with known values reporting specific characteristic.
Here, N signifies participants with known values reporting specific characteristic.
Here, N signifies participants with known values reporting specific characteristic.
| Arm | Type | Description |
|---|---|---|
| rLP2086 lot 1 | EXPERIMENTAL | - |
| rLP2086 lot 2 | EXPERIMENTAL | - |
| rLP2086 lot 3 | EXPERIMENTAL | - |
| Control | ACTIVE_COMPARATOR | Havrix (HAV) and Saline |
| rLP2086 | EXPERIMENTAL | rLP2086 and Repevax |
| Saline and Repevax | PLACEBO_COMPARATOR | Saline and Repevax |
| Name | Type | Description |
|---|---|---|
| rLP2086 | BIOLOGICAL | 0.5 mL dose, given at 0, 2 and 6 months (lot 1) |
| Havrix (HAV) | BIOLOGICAL | 0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6. |
| Saline | BIOLOGICAL | 0.5 mL dose of sterile normal saline for injection. |
| Repevax | BIOLOGICAL | 0.5 mL dose, given at 0 months. |
Inclusion Criteria: 1. Male or female subject aged \>=10 and \<19 years at the time of enrollment. 2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. 3. Negative urine pregnancy test for all female subjects. Exclusion Criteria: 1. Previous...