Prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B, A fourth (booster) dose of rMenB+OMV NZ is used to evaluate safety tolerability and immunogenicity and exploring the bactericidal antibody persistence at 12, 18 and 24 months of age. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers to generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen
Conditions
Interventions
Product Name: Novartis Meningococcal B Recombinant+OMV NZ Vaccine
Pharmaceutical Form: Suspension for injection
Other descriptive name: N. Meningitidis 287-953 purified
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Group 5: healthy 18-month-old toddlers (0/ +29 days window); Group 6: healthy 24-month-old toddlers (0/ +29 days window); 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, clinical judgment of the investigator Inclusion Criteria for follow-on participants (Groups 1, 2, 3 and 4): Inclusion criteria are the same as for Groups 5 and 6, with the addition that are subjects: 1. who participated and completed V72P12 study 2. who are aged: o 12 months or older - Groups 1a, 2a, 3a, 4 o 18 months (0/ +29 days window) - Groups 1b, 2b, 3b) o 24 months (0/ +29 days window) - Groups 1c, 2c, 3c) 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.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 (only groups 5 and 6); 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 ³ 38°C within the day before Visit 1; 7.antibiotics within 7 days prior to Visit 1; 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 Visit 1; 10.receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to Visit 1; 11.receipt of, or intent to immunize with any other vaccine(s), within 30 days prior to Visit 1; 12.participation in another clinical trial within 90 days prior to enrolment 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ in at least one of the time points, when given at 12, 18 or 24 months of age to toddlers previously primed with three doses of rMenB+OMV NZ as infants at 2, 4 and 6 months of age (with concomitant routine vaccines). ;Secondary Objective: 1.Sufficient immune response of a booster dose of rMenB+OMVNZ given at 12 or 18 or 24 months to toddlers previously primed with 3 doses of rMenB +OMVNZ (2, 4 and 6 months) without concomitant routine vaccines.2.Characterize the immune response of a booster dose of rMenB+OMVNZ (12, 18 or 24 months) to toddlers previously primed with 3 doses of rMenB+OMVNZ (2, 3 and 4 months) 3.Assess the immune response 1 month after a booster dose of rMenB+OMVNZ given at 12 or 18 or 24 months to toddlers previously primed.4.Characterize bactericidal antibody persistence in 12,18 and 24month-old toddlers previously primed.5.Characterize the induction of immunological memory in toddlers previously primed.6.Assess the immunogenicity of a 2-dose catch-up regimen of rMenB+OMVNZ in unprimed toddlers aged 12, 18 or 24 months.7.Characterize the immune response against vaccine antigen 287-953 one month after booster dose.8.Safety and tolerability of a 4 dose and of a 2-dose catch-up regimen.; Primary end point(s): The primary criterion for immunogenicity following the fourth dose of rMenB+OMV NZ is that the lower limit of the two-sided 98.3% CI for the percentage of subjects with SBA titers = 1:5 at one month following the fourth vaccination is = 75% for all three reference strains. The power for this primary endpoint is > 99%, assuming 180 evaluable subjects per group and at least 90% of the subjects showing SBA titers = 1:5 after four doses of rMenB OMV NZ for each of the three strains. If there are only 100 evaluable subjects per group the overall power will be 85%, assuming at least 90% of the subjects showing SBA | — |
Countries
Belgium, Czech Republic, Germany, Italy, Spain, United Kingdom
Outcome results
None listed