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: Subjects eligible to be enrolled in the study: 1. healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg; 2. for whom a parent/legal guardian has given written informed consent 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 and 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: Infants who should not be enrolled in the study are those: 1. whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2. who have previously received any meningococcal B vaccine; 3. who received prior vaccination with D, T, P (acellular or whole cell), IPV or OPV, H. influenzae type b (Hib) and PC7 vaccine; 4. who have a previous ascertained or suspected disease caused by N. meningitidis, S. pneumoniae, C. diphtheriae, C. tetani, Poliovirus, Hib, B. pertussis (history of laboratory confirmed, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping); 5. who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae or Polio infection since birth; 6. who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component. 7. who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (>/=38.0°C) within the previous 3 days; 8. who have any present or suspected serious acute or chronic disease (e.g., with signs of cardiac, renal failure, hepatic disease, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down’s syndrome); 9. who have leukemia, lymphomas; 10. who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example): a) receipt of any immunosuppressive therapy since birth b) receipt of immunostimulants since birth c) receipt of any sytemic corticosteroid since birth 11. with a suspected or known HIV infection or HIV related disease; 12. who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation from birth and for the full length of the study; 13. with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 14. who have experienced any seizure, either associated with fever or as part of an underlying neurological disorder or syndrome 15. who have taken antibiotics within 7 days prior to enrollment (exception: antibiotics taken once daily within 14 days after the last dose); 16. who have either received, or for whom there is intent to immunize with any other vaccine(s), with respect to the study vaccines, within 30 days prior and throughout the study period; 17. who have ever received another investigational agent from birth prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study; 18. whose parents/legal guardians, are planning to leave the area of the study site before the end of the study period; 19. with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV-NZ when administered to healthy infants at 2, 4 and 6 months of age, at 30 days after the third dose, by evaluation of the breadth of bactericidal activity (BCA) response against a panel of genetically distinct meningococcal strains. To explore the safety and tolerability of the study and concomitant vaccines in all study subjects. ; Secondary Objective: • To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV-NZ at 30 days after the second dose *. • To explore the antibody persistence of Novartis rMenB Vaccine +/- OMV-NZ at 12 months of age *. • To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV-NZ at thirty days after the fourth dose (administered at 12 months of age), *. • To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV-NZ at thirty days after the administration of a single dose given at 12 months of age *. • To explore the induction of specific antibody responses by enzyme-linked immunosorbent assay (ELISA) at 30 days after the second, the third and the fourth dose of Novartis rMenB Vaccine +/- OMV-NZ (Groups I and II) and at 30 days after the single dose administration (Groups III and IV). *= by evaluation of the breadth of BCA response against a panel of genetically distinct meningococcal strains ;Primary end point(s): To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV-NZ when administered to healthy infants at 2, 4 and 6 months of age, at 30 days after the third dose, by evaluation of the breadth of bactericidal activity (BCA) response against a panel of genetically distinct meningococcal strains. | — |
Countries
United Kingdom
Outcome results
None listed