Demonstration of a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ administered at 12 months of age, either with or without concomitant MMRV vaccination, to toddlers previously primed with three doses of rMenB+OMV NZ as infants in Study V72P13. MedDRA version: 9.1 Level: LLT Classification code 10027249 Term: Meningitis meningococcal
Conditions
Interventions
Product Name: recombinant Men B
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Meningococcus B, outer membrane vesicle vaccine
Concentration unit: mEq/µg milliequivalent(s)/microgram
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
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. Subjects eligible to be enrolled in the study should comply with the following criteria: 1. healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13; 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: Previous ascertained or suspected disease caused by N. meningitidis; 2. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 3. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 4. Significant acute or chronic infection within the previous 7 days or axillary temperature ≥ 38C within the previous day; 5. Antibiotics within 6 days prior to enrollment; 6. 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); 7. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids since birth; 8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 9. Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.10. Participation in a clinical trial other than Study V72P13 since birth or planned for during this extension study; 11. Family members and household members of research staff; 12. 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: Demonstration of a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ administered at 12 months of age, either with or without concomitant MMRV vaccination, to toddlers previously primed with three doses of rMenB+OMV NZ as infants in Study V72P13. The immune response will be assessed by the percentage of subjects with serum bactericidal assay (SBA) titers ≥ 1:5 at one month after the fourth dose, directed against N. meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99. The primary criterion to determine a sufficient immune response is that for the percentage of subjects with SBA titers ≥ 1:5 the lower limit of the two-sided 95% CI is ≥ 75% for all three reference strains.;Secondary Objective: -Demonst that the immune responses to MMRV vaccination, when administered concomitantly with the fourth (booster) dose of rMenB+OMV NZ at 12 months of age,are not inferior to the immune responses of MMRV when given alone.Assessment of the immune response following a fourth (booster) dose of rMenB+OMV NZ administered at 12 months of age, either with or without concomitant MMRV vaccination, as measured by SBA GMTs and percentage of subjects with SBA titers ≥ 1:5 at one month after the fourth dose of rMenB+OMV NZ,directed against N. meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.Evaluation of the persistence of bactericidal antibodies at 12 months of age(pre-dose 4)in infants who previously received three doses of rMenB+OMV NZ as infants in Study V72P13,as measured by SBA GMTs and the percentage of subjects with SBA titers ≥ 1:5,directed against N.meningitidis serogroup B reference strains H44/76,NZ98/254 and 5/99.;Primary end point(s): The primary criterion to determine a sufficient immune response is that for the percentage of subjects with SBA titers ≥ 1:5 the lower limit of the two-sided 95% CI is ≥ 75% for each of the three sero | — |
Countries
Austria, Czech Republic, Finland, Germany, Italy
Outcome results
None listed