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A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 o...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-011676-30

A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12

Femme et Homme

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Extrait

To demonstrate a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ in at least one of the time points, when given at 12, 18 or 24 months of age to toddlers previously primed with three doses of rMenB+OMV NZ as infants at 2, 4 and 6 months of age (with concomitant routine vaccines).

Critère d'inclusion

  • Prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B, A fourth (booster) dose of rMenB+OMV NZ is used to evaluate safety tolerability and immunogenicity and exploring the bactericidal antibody persistence at 12, 18 and 24 months of age. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers to generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen

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