The Novartis Meningococcal B recombinant vaccine is intended for prevention of meningitis and/or septicemia caused by Neisseria meningitidis serogroup B. The objective of the Novartis Meningococcal B Recombinant Vaccine program is to identify vaccine candidates that are safe and that provide functional immune responses against heterologous meningococcal B strains.
Conditions
Sponsors
Novartis Vaccines and Diagnostics Srl.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained. Inclusion Criteria for naive subjects, newly enrolled (Groups III and IV): Healthy male and female subjects will be recruited at the same study site. 1. Group III: Healthy 40 to 44-months-old children; Group IV: Healthy 60 to 62-months-old children. The age windows are defined as the first day the subject turns 40 or 60 months of age up to the day before the subject turns 45 or 63 months of age, respectively. 2. For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained; 3. Available for all the visits scheduled in the study; 4. In good health as determined by medical history, physical examination, clinical judgment of the investigator Inclusion Criteria for follow-on participants (Groups I and II): 1. Healthy 40 to 44-months-old children. The age window is defined as the first day the subject turns 40 months of age up to the day before the subject turns 45 months of age. 2. Who participated and completed the study V72P9; 3. For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained; 4. Available for all the visits scheduled in the study; 5. In good health as determined by medical history, physical examination, clinical judgment of the investigator Are the trial subjects under 18? yes Number of subjects for this age range: 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 for naïve subjects newly enrolled (Groups III and IV): 1. subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2. history of any meningococcal B vaccine administration; 3. previous ascertained or suspected disease caused by N. meningitidis; 4. household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. history of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component 6. significant acute or chronic infection within the previous 7 days or axillary temperature =38°C within the previous day; 7. antibiotics treatment within 7 days prior to enrollment, or within 14 days prior to enrollment if in a once-a-day treatment regimen; 8. any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9. known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion); 10. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment; 11. receipt of, or intent to immunize with any other vaccine(s) within 30 days prior and after any vaccination with the investigational vaccines (exception: flu-vaccines should not be administered within 14 days prior and after any vaccination with the investigational vaccines); 12. participation in another clinical trial within 90 days prior to enrollment or planned for during study; 13. family members and household members of research staff; 14. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Exclusion Criteria for follow-on participants (Groups I and II): Exclusion criteria are the same as for Groups III and IV, with the exception of criterion 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Immunogenicity Endpoints: Serum bactericidal activity will be measured against N. meningitidis serogroup B indicator strains H44/76, NZ98/254 and 5/99. Data will be summarized by calculating SBA geometric mean titers (GMTs), percentage of subjects with SBA titers = 1:4 and =1:8, and additionally =1:5 (strains H44/76, NZ98/254 and 5/99), and percentage of subjects with fourfold increase over baseline. Antibody responses to vaccine antigen 287-953 will be determined by ELISA and summarized by geometric mean concentrations (GMCs) and four-fold rises. Antibody persistence and immune responses will be interpreted using data from the naïve groups of children recruited at 40 and 60 months of age, as indicated below. Baseline antibody levels measured in naïve subjects at 40 months of age (Group III) will serve as a descriptive comparator to evaluate antibody persistence at 40 months of age for Groups I and II. Responses to the first catch-up dose of rMenB+OMV NZ administered to naïve subjects at 40 months of age (Group III) will serve as a descriptive comparator to evaluate the booster response and, in turn, the presence of immunological memory in Groups I and II. Baseline antibody levels measured in naïve subjects at 60 months of age (Group IV) will serve as a descriptive comparator to evaluate antibody persistence at 60 months of age post-boost in Groups I and II and post-two catch-up doses in Group III. Safety Endpoints: All subjects who receive at least one dose of investigational vaccine and provide post-vaccination safety data (defined as the safety population) will be included in the safety and tolerability analyses. All safety analyses will be descriptive. ; Main Objective: The present study, V72P9E1, is an extension of V72P9. The primary objective of this extension study will be to evaluate bactericidal antibody persistence at approximat | — |
Countries
United Kingdom
Outcome results
None listed