Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls.

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.

Inclusion Criteria:

Inclusion criterion applicable to All Groups

• Subjects aged 2 to 17 years (inclusive) at enrollment
• weighing at least 13 Kg at the time of enrollment

Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies

Inclusion criterion applicable to Group B

- Subjects at risk of meningococcal disease because of functional or anatomic asplenia

Inclusion criterion applicable to Group C - healthy subjects

Exclusion Criteria:

Exclusion criteria applicable to All Groups (A, B and C)

• History of any previous immunization with a meningococcal B vaccine
• History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine
• Known HIV infection
• History of any progressive or severe neurologic disorder or seizure disorder
• Contraindication to intramuscular injection or blood drawn
• Females who are pregnant, planning a pregnancy or nursing (breastfeeding)
• Females of childbearing potential who have not used or do not plan to use acceptable birth control measures
• History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects

Exclusion criterion applicable to Groups A and B

- Previous known or suspected disease caused by N. meningitidis in the last year.

Exclusion criteria applicable to Group C

• Previous known or suspected disease caused by N. meningitidis
• Known or suspected impairment/alteration of the immune system