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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00657709 | Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants | PHASE3 | COMPLETED | 3,630 | — | — | Mar 1, 2008 | Jan 1, 2010 | Oct 10, 2017 | 66 | Austria, Czechia +3 |
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
| Arm | Type | Description |
|---|---|---|
| rMenB Lot1 | EXPERIMENTAL | Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| rMenB Lot2 | EXPERIMENTAL | Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| rMenB Lot3 | EXPERIMENTAL | Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. |
| Routine | ACTIVE_COMPARATOR | Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. |
| MenC + Routine | ACTIVE_COMPARATOR | Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. |
| Name | Type | Description |
|---|---|---|
| Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1) | BIOLOGICAL | One dose of rMenB Lot concomitantly with the routinely administered infant vaccines |
| Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2) | BIOLOGICAL | One dose of rMenB concomitantly with the routinely administered infant vaccines |
| Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3) | BIOLOGICAL | One dose of rMenB concomitantly with the routinely administered infant vaccines |
| Infanrix Hexa | BIOLOGICAL | Routine vaccination |
| Menjugate | BIOLOGICAL | One dose of the routinely administered infant vaccines + MenC vaccine |
| Prevenar | BIOLOGICAL | Routine vaccination |
Inclusion Criteria: * Healthy 2-month old infants (55-89 days, inclusive) Exclusion Criteria: * Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens) * Previous ascertained or suspected disease caused...