The Novartis Meningococcal B Recombinant + OMV NZ Vaccine is intended for prevention of meninigitidis and/or septicemia caused by N. meningitidis serogroup B. The objective of the Novartis Meningococcal B Recombinant + OMV NZ Vaccine is to identify a vaccine candidate that is safe and provide functional immune responses against heterologous meningococcal B strains.
Conditions
Sponsors
Novartis Vaccines and Diagnostics S.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: 1. History of any meningococcal B or C vaccine administration; 2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens; 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 rectal temperature >/= 38°C within the previous day; 7. Antibiotics within 6 days prior to enrollment; 8. Any serious chronic or progressive disease in the opinion of the investigator (e.g., neoplasm, diabetes, 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, such as immunosuppressive therapy, including use of corticosteroids or chronic use of inhaled high-potency corticosteroids since birth (e.g., 1 mg/kg/day of prednisone [or its equivalent]); budesonide 800 mcgg per day or fluticasone 750 mcg per day). [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunogenicity of 3 doses of rMenB+OMV NZ (3 lots combined) given to healthy infants at 2, 4 and 6 months of age concomitantly with routine infant vaccines, by evaluation of the serum bactericidal activity (SBA), at 1 month after the third vaccination. To show the consistency of immune response from 3 lots of rMenB+OMV NZ, by serum bactericidal activity geometric mean titer response (SBA GMTs), when administered to healthy infants at 2, 4 and 6 months of age, at 1 month after the third vaccination. ;Secondary Objective: To assess the consistency of immune response from 3 lots of rMenB+OMV NZ, as measured by percentage of subjects with SBA titer =1:4 when administered to healthy infants at 2, 4 and 6 months of age, at 1 month after the third vaccination. To demonstrate that the immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4 and 6 months of age, is non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. To asses the prevalence of meningococcal B antibodies over the study period by evaluation of the serum bactericidal activity (SBA), at baseline and at 1 month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ. ;Primary end point(s): . Bactericidal activity (>/=1:4 i.e. percentage of subjects with SBA titer >/=1:4) 30 days following the third vaccination (receiving either rMenB+OMV NZ (Lot 1, Lot 2 and Lot 3) .The immune response for the for the Norwegian strain H44/76 and New Zealand strain NZ98/254 will be sufficient if the lower limit of the 95% CI for the % >/=1:4 for the three lots combined is >/=70% and is >/=50% for strain 5/99. If the immunogenicity response for the three strains for the three lots combined is sufficient then: . Immunogenicity of the 3 lots of rMenB+OMV NZ will be considered equivalent if, for each of the 3 strains and each pair of vaccine lots, the two-sided 95% CI on the ratio of GMTs at | — |
Countries
Austria, Czech Republic, Finland, Germany, Italy
Outcome results
None listed