Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B.

• Conditions: Meningococcal Group B disease.; MedDRA version: 16.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002454-78-ES
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-10
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria applicable to the relevant group.
Inclusion criteria applicable to All Groups (A, B and C)
1.Subjects aged 2 to 17 years (inclusive) at enrollment;
2.who have given written informed assent (if appropriate) and whose parent/legal guardian have given written informed consent after the nature of the study has been explained;
3.available for all the visits scheduled in the study;
4.weighing at least 13 Kg at the time of enrollment.
Inclusion criterion applicable to Group A
5.Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies:
a.Primary deficiencies: patients with a congenital condition leading to a reduced concentration of one or more proteins in the complement cascade, including C1 (q,r,s), C2, C3, C4, Factor D, Properdin, C5, C6, C7, C8, C9, Factor H, Factor I (homozygous)
b.Secondary deficiencies: patients with a condition indirectly leading to a reduced concentration of one or more proteins in the complement cascade, including patients who are already in treatment with eculizumab at the time of enrollment and have been diagnosed with paroxysmal nocturnal hemoglobinuria or with atypical hemolytic uremic syndrome
For patients with a secondary complement deficiency the investigator should include in the source documentation evidence of the increased risk of meningococcal disease based on reduced complement protein concentrations or on previous meningococcal infection. This should be documented in the medical records.
Inclusion criterion applicable to Group B
6.Subjects at risk of meningococcal disease because of functional or anatomic asplenia:
a.Congenital anomalies of the spleen, isolated or in association with other splenic anomalies
b.Surgical splenectomy, which may occur after significant splenic trauma or other clinical disorders, such as idiopathic (autoimmune) thrombocytopenic purpura
c.Autosplenectomy (i.e. infarction) which may occur in patients with sickle cell disease or other haemoglobinopathies
For patients with functional asplenia the investigator will collect medical documentation for reduced splenic function diagnosed with an appropriate technique. Patients with anatomic asplenia or sickle-cell disease do not require assessment of the splenic function.
Inclusion criterion applicable to Group C
7.healthy immunocompetent subjects, in good health as determined by medical history, physical examination and clinical judgment of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria applicable to All Groups (A, B and C)
1. History of any previous immunization with a meningococcal B vaccine at the time of
enrollment;
2. History of severe allergic reaction after previous vaccinations, or hypersensitivity to
any component of the vaccine;
3. Known HIV infection;
4. History of any progressive or severe neurologic disorder, or seizure disorder
(exception: one self-limited febrile seizure is acceptable);
5. Contraindication to intramuscular injection or blood drawn;
6. Females who are pregnant, planning a pregnancy or nursing (breastfeeding);
7. Females of childbearing potential who have not used or do not plan to use acceptable
birth control measures, for the 3 months duration of the study. Oral, injected or
implanted hormonal contraceptive, barrier methods (diaphragm or condom with
spermicide), intrauterine device or sexual abstinence are considered acceptable forms
of birth control. If sexually active the subject must have been using one of the
accepted birth control methods for at least 60 days prior to study entry
8. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all
required study procedures for the whole period of the study;
9. Intent to participate in another clinical study during this study;
10. Family members or household members of site research staff;
11. 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 due to participation
in the study.
Exclusion criterion applicable to Groups A and B
12. Previous known or suspected disease caused by N. meningitidis in the last year;
Exclusion criteria applicable to Group C
13. Previous known or suspected disease caused by N. meningitidis;
14. Known or suspected impairment/alteration of the immune system resulting from, for
example, receipt of immunosuppressive/immunostimulant therapy
There may be instances when individuals meet all entry criteria except one that relates to
transient clinical circumstances (e.g., body temperature elevation or recent use of
excluded medication or vaccine). Under these circumstances, a subject may be
considered eligible for study enrollment if the appropriate window for delay has passed,
inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be
eligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified