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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00847145 | Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers | PHASE3 | COMPLETED | 2,249 | — | — | Feb 1, 2009 | Aug 1, 2010 | Mar 3, 2015 | 59 | Austria, Czechia +3 |
Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.
| Arm | Type | Description |
|---|---|---|
| 12B12M (1a) | EXPERIMENTAL | Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study. |
| 12B13M (1b) | EXPERIMENTAL | Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study. |
| 12M13B15B (2a) | EXPERIMENTAL | Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study. |
| 12M12B14B (2b) | EXPERIMENTAL | Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study. |
| 12B12M (3a) | EXPERIMENTAL | Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study. |
| 12B13M (3b) | EXPERIMENTAL | Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study. |
| 12B12M_C (4a) | EXPERIMENTAL | Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study. |
| 12B13M_C (4b) | EXPERIMENTAL | Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study. |
| Name | Type | Description |
|---|---|---|
| 1a - rMenB+OMV NZ and routine vaccines | BIOLOGICAL | One dose of rMenB vaccine and routine vaccine at study month 12. |
| 1b - rMenB+OMV NZ and routine vaccines | BIOLOGICAL | One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13. |
| 2a - Routine and rMenB+OMV NZ vaccines | BIOLOGICAL | One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15. |
| 2b - rMenB+OMV NZ and routine vaccines | BIOLOGICAL | Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12. |
| 3a - rMenB+OMV NZ and routine vaccines | BIOLOGICAL | One dose of rMenB vaccine and one dose of routine vaccine at study month 12. |
| 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations | BIOLOGICAL | One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13. |
| 4a- rMenB+OMV NZ and routine vaccines | BIOLOGICAL | One dose of rMenB vaccine and one dose of routine vaccine at study month 12. |
| 4b - rMenB+OMV NZ and routine vaccines | BIOLOGICAL | One dose of rMenB vaccine and one dose of routine vaccine at study month 12. |
Inclusion Criteria: * Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13 Exclusion Criteria: * Previous ascertained or suspected disease caused by N. meningitidis; * History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; *...