Meningococcal Group B disease. MedDRA version: 16.1 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Bexsero, meningococcal group-B vaccine
Product Name: Meningococcal Group B Vaccine (Bexsero)
Product Code: rMenB+OMV NZ
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: n
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objective ? To evaluate the immunogenicity of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in healthy age-matched subjects, at 1 month after the second vaccination. Safety Objective ? To assess the safety and tolerability of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in healthy age-matched subjects.;Secondary Objective: Not applicable;Primary end point(s): Primary Endpoint(s) ? Percentage of subjects with hSBA titers = 5, hSBA titers = 8 and hSBA Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain at baseline and one month after the second vaccination. Corresponding to the GMTs, within-subject Geometric Mean Ratios (GMRs), at one month after the second vaccination over baseline. ? Percentage of subjects with four-fold increases in hSBA titers against each of the serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain at one month after the second vaccination over baseline. ? ELISA geometric mean concentrations (GMCs), to evaluate antibody responses to vaccine antigen 287-953, at baseline and at one month after the second vaccination. Corresponding to the GMCs, within-subject ELISA GMRs, at one month after the second vaccination over baseline. ? Percentage of subjects with four-fold increases in ELISA concentrations, to evaluate antibody responses to vaccine antigen 287-953, at one month after the second vaccination over baseline. Safety Endpoints ? The frequencies and percentages of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after Visits 1 and 2. ? The frequencies and percentages of subjects with any other (unsolicited) AEs including any SAEs, AEs leading to withdrawal and medically attended AEs during the 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Italy, Poland, Russian Federation, Spain, United Kingdom
Contacts
Public ContactClinical Cluster
Novartis Vaccines and Diagnostics S.r.l.
Outcome results
None listed