Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

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

To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.

Inclusion Criteria:

• healthy 6-8 months old infants

Exclusion Criteria:

• previous receipt of any meningococcal B vaccine;
• previous ascertained or suspected disease caused by N meningitidis;
• history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
• any present or suspected serious acute or chronic disease
• known or suspected autoimmune disease or impairment /alteration of immune function