Immunogenicity and safety of a Meningococcus B Brazilian vaccine

INTERVENTION: Randomised open‐label study with four arms: 1. Men‐B‐Bio 12.5 µg 2. Men‐B‐Bio 25 µg 3. Men‐B‐Bio 50 µg 4. Similar Cuban vaccine (reference vaccine) At the end of the study we expect to choose the best dose for the Brazilian vaccine. Total duration: 20 months Total duration of follow up: 20 months Blood samples: before 1st dose, before 3rd dose and 1 month after 3rd dose The second (25 µg) and third (50 µg) concentration groups will start after completion of the first concentration (12.5 µg) evaluation, hence the extension of the study to 20 months of follow up. CONDITION: Meningococcus B disease ; Infections and Infestations ; Meningococcal infection PRIMARY OUTCOME: Seroconversion (bactericidal titre from seronegative to greater than or equal to 1/4 or four‐fold increase in titre). Timepoints at the point of blood collection; before 1st dose, before 3rd dose and 1 month after 3rd dose. SECONDARY OUTCOME: Reactogenicity similar to the reference vaccine, measured 1 month of follow up after each dose for solicited events and for the entire study duration for all other events. INCLUSION CRITERIA: 1. Both sexes 2. Aged between 4 years and 12 years 3. Agreement with Free and Informed Consent Form 4. Healthy children