A Phase 3, Open label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13

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Extract

Demonstration of a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ administered at 12 months of age, either with or without concomitant MMRV vaccination, to toddlers previously primed with three doses of rMenB+OMV NZ as infants in Study V72P13. The immune response will be assessed by the percentage of subjects with serum bactericidal assay (SBA) titers ≥ 1:5 at one month after the fourth dose, directed against N. meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99. The primary criterion to determine a sufficient immune response is that for the percentage of subjects with SBA titers >= 1:5 the lower limit of the two-sided 95% CI is ≥ 75% for all three reference strains.

Inclusion criteria

An open-label extension study in subjects who previously participated and completed Study V72P13. Subjects will be assigned to receive either a fourth dose of rMenB+OMV NZ, or one or two-dose catch-up regimens of rMenB+OMV NZ according to whether they received three doses of rMenB+OMV NZ with routine vaccinations or routine vaccinations only as infants in V72P13. Subjects will be recruited from the same sites as in V72P13 in Europe

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A Phase 3, Open label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months...