The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.
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Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine)
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Timeframe: Day 91 (one month after the second dose of the study vaccine).
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Timeframe: Day 1 and Day 91 (one month after the second dose of the study vaccine).
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.
Timeframe: Day 91 (one month after the second dose of the study vaccine).
Number Of Subjects With Unsolicited Adverse Events (AEs).
Timeframe: At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)