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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 combination vaccine being studied for the prevention of Meningococcal Disease, a serious bacterial infection. It is in Phase 3 clinical development and is intended for use in healthy toddlers as a booster or catch-up vaccination.
1a-rMenB+OMV NZ and routine vaccines is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine candidate for Meningococcal Disease.
1a-rMenB+OMV NZ and routine vaccines is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in preventing Meningococcal Disease.
1a-rMenB+OMV NZ and routine vaccines is being evaluated in a completed Phase 3 trial with the identifier NCT00847145. This study, titled '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,' enrolled 2,249 participants.
Yes, 1a-rMenB+OMV NZ and routine vaccines is the same as the Novartis Meningococcal B Recombinant Vaccine. The clinical trial NCT00847145 refers to this vaccine candidate, which is being studied for its ability to protect against Meningococcal Disease in healthy toddlers.