Prevention of meningococcal disease caused by serogroup B Neisseria meningitidis by evaluating the Antibody persistence in 4-year old healthy children who previously received the Novartis meningococcal B Recombinant vaccine (rMenB+OMV NZ) as infants in study V72P12 and received a booster dose in study V72P12E1 and characterizing the antibody response to a fifth or a third booster dose or two catch-up doses of the rMenB+OMV NZ vaccine at 4 years of age.
Conditions
Interventions
Product Name: Novartis Meningococcal B Recombinant + OMV NZ Vaccine
Product Code: rMenB+OMV NZ
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor co
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. A) Inclusion Criteria for naive subjects, newly enrolled (Group 7): 1. 4 years old (48 -60 months) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. The age window is defined as the first day the subject turns 4 years old up to the day before the subject turns 5 years old. 2. for whom a parent/legal guardian(s) has given written informed consent after the nature of the study has been explained; 3. for whom a parent/legal guardian(s) confirmed availability for the visit scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator. B) Inclusion Criteria for follow-on participants (Groups 1, 2, 3, 4, 5, and 6): Inclusion criteria are the same as for Groups 7, with the addition that they are subjects who completed the vaccination course of V72P12E1 study. Are the trial subjects under 18? yes Number of subjects for this age range: 1700 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: A)Exclusion Criteria for naïve subjects, newly enrolled (Group 7):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; 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 allergic reaction to any vaccine component; 6.significant chronic infection; 7.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);8. known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants;9. participation in another clinical trial within 90 days prior to enrolment or planned for during study; 10. family members and household members of research staff. 11; any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. B. Exclusion Criteria for follow-on participants (Groups 1, 2, 3, 4, 5, and 6): Exclusion criteria are the same as for Group 7, with the exception of criterion 2 and excluding partecipation in V72P12E2 for criterion 9.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV administered at either 12, 18, or 24 months of age in study V72P12E1, in toddlers who previously received a three-dose primary series of rMenB+OMV (at 2, 3, 4 or 2, 4, 6 months of age) as infants in the original parent study V72P12.;Secondary Objective: To explore antibody persistence in 4-year-old children after two catch-up doses of rMenB+OMV administered to toddlers at 12 and 14, 18 and 20, or 24 and 26 months of age in study V72P12E1. To characterize the antibody response to a fifth dose boost of rMenB+OMV administered to 4-year-old children after a fourth dose boost of rMenB+OMV, previously given to toddlers at 12, 18, or 24 months of age in study V72P12E1. To characterize the antibody response to a third dose boost of rMenB+OMV administered to 4-year-old children after two catch-up doses of rMenB+OMV, previously administered to toddlers at either 12 and 14, 18 and 20, or 24 and 26 months of age in study V72P12E1. To demonstrate a sufficient immune response to two catch-up doses of rMenB+OMV NZ administered 2 months apart to naïve 4-year-old children. ;Primary end point(s): For Groups 1 to 3: The persistence of serum bactericidal activity at 4 years of age will be measured against N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713. Data will be summarized by calculating percentage of subjects with hSBA= 1:5, hSBA = 1:8, hSBA geometric mean titers (GMTs), and geometric mean ratio (GMRs) over baselines at 4 years of age after the last rMenB+OMV NZ vaccination in the V72P12E1 study), to each of the four indicator strains. All immunogenicity analyses will be erformed on the MITT population.;Timepoint(s) of evaluation of this end point: At 4 years of age after last vaccination with rMenB+OMV NZ in parent trial V72P12E1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For Groups 4 to 6: The persistence of serum bactericidal activity at 4 years of age will be measured against N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713. Data will be summarized by calculating percentage of subjects with hSBA= 1:5, hSBA = 1:8, hSBA geometric mean titers (GMTs), and geometric mean ratio (GMRs) over baselines at 4 years of age after the last rMenB+OMV vaccination in the V72P12E1 study), to each of the four indicator strains. All immunogenicity analyses will be performed on the ITT population. For subset#2 of groups 1 and 2 (1/3 of each sub-group) and for all group 3:induction of bactericidal antibodies at 1 month following a fifth dose boost of rMenB+OMV vaccination will be characterized by calculating SBA GMTs, percentage of subjects with hSBA titers = 1:5 and = 1:8, and fourfold increase to each of the four indicator strains. For Groups 4 to 6: induction of bactericidal antibodies at 1 month following a third dose boost of rMenB+OMV vaccination will be characterized by calculating SBA GMTs, percentage of subjects with SBA titers = 1:5 and = 1:8, and fourfold increase to each of the four indicator strains. • A sufficient immune response of rMenB+OMV NZ, when given as a two-dose series to healthy naïve children (Group 7) at 48 and 50 months of age will be defined as the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA = 1:5 being = 70% for all three indicator strains. Analysis on strain M10713 for naïve group will be descriptive. Baseline antibody levels measured in naïve subjects at approximately 4 years of age (Group 7) will serve as a descriptive comparator to evaluate antibody persistence at 4 years of age after the fourth rMenB+OMV dose in Groups 1 to 3, and after second dose in Groups 4 to 6, in V72P12E1 study. The immune response following the first dose will also serve as a comparator for the booster responses in the above mentioned vaccine groups. | — |
Countries
Czech Republic, Italy, Spain, United Kingdom
Contacts
Public ContactRoberta Rossi
Novartis Vaccines and Diagnostics S.r.l.
Outcome results
None listed