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1a- rMenB+OMV NZ and routine vaccines · 1 trial · 1 indication
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; *...
1a- rMenB+OMV NZ and routine vaccines is an investigational vaccine regimen studied for the prevention of meningococcal disease. It combines a recombinant meningococcal B vaccine with routine childhood vaccines. It was developed by Novartis AG and evaluated in a Phase 3 clinical trial in healthy toddlers.
It is being studied for use in meningococcal disease, specifically to evaluate whether the meningococcal B recombinant vaccine can be given alongside routine vaccines in healthy toddlers. The research assessed safety, tolerability and immune response when administered as a booster or as a two-dose catch-up schedule.
Novartis AG, which trades under the ticker NVS, developed 1a- rMenB+OMV NZ and routine vaccines. The vaccine candidate was studied in a Phase 3 extension trial sponsored by the company across sites in Austria, Czechia, Finland, Germany and Italy.
1a- rMenB+OMV NZ and routine vaccines is in Phase 3 development. The single registered trial, NCT00847145, has been completed, and no active trials are currently listed. It is an investigational vaccine and is not described as approved.
It was studied in one Phase 3 trial, NCT00847145, an extension study of V72P13 that evaluated the safety, tolerability and immunogenicity of the Novartis meningococcal B recombinant vaccine when given as a booster or as a two-dose catch-up to healthy toddlers. The trial enrolled 2,249 participants and is completed.