A phase IIIB, Open Label, Multi Center extension study of V72_28 to assess antibody persistence, and the safety and tolerability of a booster dose after the completion of the vaccination course in study V72_28. MedDRA version: 16.1 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Bexsero
Product Name: Novartis Meningococcal B Recombinant +OMV NZ Vaccine
Product Code: -
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sp
Sponsors
Novartis Vaccines and Diagnostics s.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who participated in the V72_28 study (Follow-on Subjects): 1. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 2. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 3. in good health as determined by medical history, physical examination, clinical judgment of the investigator 4. who have completed the vaccination course in the V72_28 study and have received their last vaccination 24 to 36 months before enrollment in V72_28E1 Naïve subjects newly enrolled: 1. Healthy subjects according to the following age groups: a) Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age). b) Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age). c) Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age). 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. for whom a parent/legal guardian 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 Are the trial subjects under 18? yes Number of subjects for this age range: 1350 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: Naïve subjects newly enrolled: 1. History of any serogroup B meningococcal vaccine administration; 2. Previous known or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization; 4. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine; 5. Pregnancy or nursing (breastfeeding) others; 6. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry; 7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example): - Receipt of any chronic immunosuppressive therapy - Receipt of any chronic immunostimulants - Immune deficiency disorder, or known HIV infection 8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable). 9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 10. Subject' s parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 11. Intent to participate in another clinical study during this study. 12. Family members and household members of study staff; 13. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study. 14. Any significant chronic infection. 15. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). Subjects who articipated in the V72_28 study (Follow-on Subjects): Exclusion criteria are the same as for naïve subjects, with the exception of criterion 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antibody persistence 24 to 36 months after the completion of the vaccination course, in subjects who participated in the V72_28.;Secondary Objective: Secondary Immunogenicity Objectives -To evaluate the immune response at one month after a booster dose administered 24 to 36 months after completion of the vaccination course in the parent study (Groups A, C, E, G and I). -To evaluate the immune response of two catch-up doses of rMenB+OMV NZ administered 1 month apart to naïve children (Group K, L and M). Safety Objectives: To assess the safety and tolerability of rMenB + OMV NZ when given as a booster dose administered 24 to 36 months after completion of the vaccination course in subjects who participated in the V72_28, and to assess the safety and tolerability of rMenB + OMV NZ when given as a two dose regimen (0, 1 month schedule) to naïve subjects.;Primary end point(s): PRIMARY ENDPOINTS - Percentage of subjects with hSBA titers = 4 and = 5 directed against the indicator strains of N. meningitidis serogroup B H44/76, 5/99, NZ98/254 and M10713 strain. - Percentage of subjects with hSBA titers = 8 against the indicator strains of N. meningitidis serogroup B H44/76, 5/99, NZ98/254 and M10713 strain . - hSBA GMTs directed against indicator strains of N. meningitidis serogroup B H44/76, 5/99, NZ98/254 and M10713 strain. - hSBA GMRs directed against N. meningitidis serogroup B, at 24 - 36 months after the completion of the vaccination course in the parent study (Visit 1 of V72_28E1) over: - Groups A to J: 1 month after the completion of the vaccination course in the parent study (post-primary-vaccination visit ). - Group G to J: pre-primary-vaccination (Visit 1 of V72_28). SECONDARY ENDPOINTS See protocol;Timepoint(s) of evaluation of this end point: At Visit 1 (Pre-Vaccination), Visit 2 (1 month post 1st dose) and Visit 3 (1 month post 2nd dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As per protocol (refer to protocol section 7.1.2);Timepoint(s) of evaluation of this end point: As per protocol (refer to protocol section 7.1.2) | — |
Countries
Brazil, Hungary, Spain
Contacts
Public ContactStudy Start-up Associate
ICON Clinical Research Ltd
Outcome results
None listed