A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered with or...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-001592-30

A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered with or without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

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Extrait

Immunogenicity Objective: To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:5 at 1 month after the third vaccination Safety Objective: To assess the safety and tolerability of 3 doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines (i.e., combined DTaP-IPV-HBV-Hib vaccine and pneumococcal conjugate vaccine) at 2, 4 and 6 and 2, 3 and 4 months of age, or alone at 2, 4 and 6 months of age.


Critère d'inclusion

  • The Novartis Meningococcal B Recombinant + OMV NZ Vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B. The objective of the Novartis Meningococcal B Recombinant + OMV vaccine is to identify a vaccine candidate that is safe and provide functional immune responses against heterologous meningococcal B strains