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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06995430 | A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years Old) | PHASE3 | COMPLETED | 312 | — | — | Jul 7, 2025 | Dec 15, 2025 | Apr 21, 2026 | 17 | Finland, Italy +2 |
| Arm | Type | Description |
|---|---|---|
| Primed group | EXPERIMENTAL | Participants who were primed with rMenB+OMV NZ in a 2+1 or 3+1 schedule during the first 2 years of life will receive 1 dose of rMenB+OMV NZ at Day 1. |
| Naive group | ACTIVE_COMPARATOR | Participants who are group B-meningococcal-vaccine-naive within the same age range as the primed group receive 2 doses of rMenB+OMV NZ at Day 1 and Day 31. |
| Name | Type | Description |
|---|---|---|
| rMenB+OMV NZ vaccine | BIOLOGICAL | 1 dose in the Primed group or 2 doses in the Naive group. |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: For primed group only: • Participated who were primed with rMenB + OMV NZ in only either 3+1 or 2+1 schedule during the first 2 years of life as confirmed by electronic or paper ...