Groups 1a, 1b, 2a and 2b: From the last study visit in V72P13E1 to the start of the study V72P13E2 (Day 1):assessment of immunogenicity or safety Group 3: From birth to the start of the study V72P13E2 (Day 1), 30 minutes after each vaccination:Immediate reactions, For 7 days after each vaccination: body temperature
Conditions
Interventions
Product Name: Novartis Meningococcal B Recombinant+OMV NZ vaccine
Pharmaceutical Form: Suspension for injection
Other descriptive name: N. meningitidis 961c purified antigen
Concentration unit: µg/ml
Sponsors
Novartis Vaccines and Diagnostics S.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group 3:naive subjects:Healthy male and female children, 23 to 27 months of age; 2. For whom parent(s)/legal guardian(s) have given written informed consent 3. Available for all the visits scheduled in the study;4. In good health Groups 1a, 1b, 2a and 2b follow-on participants: 1. Healthy children who have participated in the immunogenicity part of V72P13E1 and have received their last vaccination 12 months (-30/+60 days) before enrollment in V72P13E2. 2. Who have received all vaccinations with rMenB+OMV NZ in V72P13 and V72P13E1 3. Who have provided at least the blood sample one month after their fourth dose of rMenB+OMV NZ (Groups 1a/1b) or after their second dose of rMenB+OMV NZ (Groups 2a/2b) in V72P13E1 according to the protocol. see protocol page 44 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 (Group 3): 1. Subjects whose parent(s)/legal guardian(s) 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 >= 38Centigrade within the previous day; 7. Antibiotics treatment within 6 days prior to enrollment; for other point see protocol page 44 Exclusion Criteria for follow-on participants (Groups 1a, 1b, 2a and 2b): Exclusion criteria are the same as for the naïve subjects (Group 3), with the exception of criterion 2 which does not apply to these previously vaccinated subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity :To explore antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ, administered at 12 months of age to toddlers enrolled in study V72P13E1 who previously received a three-dose primary series of rMenB+OMV NZ (administered at 2, 4 and 6 months of age) as infants in the original parent study V72P13. Safety:a.To assess the safety and tolerability of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to toddlers at either 12 and 14 or 13 and 15 months of age in study V72P13E1.plus assess the safety and tolerability of two catch-up doses of rMenB+OMV NZ administered to naïve children at 24 and 26 months of age.;Secondary Objective: a. explore antibody persistence at one year after two catch-up doses previously administered to 12, 14 or 13,15 months of age in study V72P13E1. b.characterize the antibody response to a booster (third) dose administered at one year after two catch-up doses previously administered to 12,14 or 13,15 months of age in study V72P13E1. •explore antibody persistence at 6 months after a booster (third) dose adm. one year after two catch-up doses of rMenB+OMV NZ in the second year of life. c.To characterize the antibody response to two catch-up doses of rMenB+OMV NZ administered to naïve children at 24 and 26 months of age. •To explore antibody persistence at 6 months after two catch-up doses of rMenB+OMV NZ administered to naïve children at 24 and 26 months of age ;Primary end point(s): Immunogenicity Endpoints Primary: Serum bactericidal activity B indicator strains H44/76, 5/99 and NZ98/254. Antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ (Groups 1a and 1b) will be assessed bycalculating SBA geometric mean titers (GMTs) and the percentage of subjects . Antibody responses to vaccine antigen 287-953 will be determined by ELISA and summarized by geometric mean concentrations (GMCs). Sa | — |
Countries
Czech Republic, Finland
Outcome results
None listed