Meningococcal Group B disease. MedDRA version: 17.0 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Bexsero, Meningococcal group B Vaccine (rDNA, component, adsorbed)
Product Name: Meningococcal group B Vaccine (Bexsero)
Product Code: rMenB+OMV NZ
Pharmaceutical Form: Suspension for inje
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Individuals of 18 through 50 of age on the day of informed consent. 2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Individuals who can comply with study procedures including follow-up*. 4. Males Or Females of non-childbearing potential* Or Females of childbearing potential who are using an effective birth control method* which they intend to use for at least 30 days after the last study vaccination. Prior to receipt of the second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations. *Please refer to the footnote of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Each subject must not have: 1. Progressive, unstable or uncontrolled clinical conditions. 2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study. 3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 4. Body weight = 50 Kg at the time of informed consent 5. Abnormal function of the immune system resulting from: a. Clinical conditions. b. Systemic administration of corticosteroids (PO/IV/IM) at any dose and for any duration within 90 days prior to informed consent. c. Administration of antineoplastic and immunomodulating agents or radiotherapy at any dose and for any duration within 90 days prior to informed consent. 6. Received immunoglobulins or any blood products at any dose and for any duration from 3 months prior to informed consent. 7. Must not have chronic clinical significant conditions 8. Received an investigational or non-registered medicinal product within 30 days prior to informed consent 9. Study personnel as an immediate family or household member 10. Been administered any group B meningococcal vaccine at any time prior to informed consent. 11. Current or previous, confirmed or suspected disease caused by N. meningitidis. 12. Tested positive at the baseline pregnancy test. 13. Nursing (breastfeeding) mothers; 14. Any clinical condition manifesting in abnormal metabolic, hematological or cardiocirculatory measurements, including conditions which would so manifest if left untreated. 15. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. Prior to receipt of the second administration of the study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects meet any of the original exclusion criteria listed above, they should not receive additional vaccinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Immunogenicity Objective Establish a control sera panel using pre- and post-vaccination blood donations to be used as a reference in SBA tests Primary Safety Objective To assess the safety of two doses of rMenB+OMV NZ in healthy adult subjects;Secondary Objective: Not applicable;Primary end point(s): Primary Safety Endpoint(s) Safety of the study vaccines will be assessed in all subjects in terms of the frequency of reported adverse events including: - Any unsolicited AEs reported within 30 minutes after each vaccination; - Medically-attended AEs reported during the entire study period; - AEs leading to premature withdrawal from the study during the entire study period; - SAEs reported during the entire study period.;Timepoint(s) of evaluation of this end point: The study comprises four clinical visits (pre-vaccination, Day 1, Day 61, and Day 91). The pre-vaccination and Day 1visits may be combined. All subjects will undergo 2 blood donations. Blood (approximately 150 mL) will be drawn from all subjects before first vaccination (Day 1) and 1 month after the second vaccination (Day 91). Vaccinations will be given to all subjects at Day 1 and Day 61 (Visits 1 and 2). Subjects will be observed for at least 30 minutes after each vaccination for any immediate reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Poland
Contacts
Public ContactClinical Cluster
Novartis Vaccines and Diagnostics S.r.l.
Outcome results
None listed