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A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults...

Mise à jour : Il y a 5 ans
Référence : EUCTR2012-005815-25

A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive

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Extrait

To assess the immune response, SBA will be performed against the N. meningitidis serogroup B indicator strains H44/76, NZ98/254 and 5/99 at one month after a vaccination course of two doses of rMenB + OMV NZ administered two months apart.

Critère d'inclusion

  • A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive

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