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A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants 6-...

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Reference: EUCTR2006-005589-38

A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants 6-8 months old

Woman and Man

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Extract

To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV when administered to healthy infants, at 30 days after the second and the third dose, by evaluation of the breadth of bactericidal activity (BCA) response against a panel of genetically distinct meningococcal strains. To explore the safety and tolerability of Novartis rMenB with or without OMV throughout the clinical study.

Inclusion criteria

  • The Novartis Meningococcal B Recombinant +/- OMV Vaccine is intended for prevention of meningitidis and/or septicemia cause by Neisseria menigitidis serogroup B. The objective of the Novartis Meningococcal B Recombinant +/-OMV Vaccine is to identify vaccine candidates that are safe and that provide functional immune responses against heterologus meningococcal B strains

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