A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive. MedDRA version: 14.1 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
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not applicable
Other descriptive name: OUTER
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 – 65 years of age inclusive who have given written informed consent at the time of enrollment; Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); In good health as determined by medical history, physical examination and clinical judgment of the investigator; Who are or might be routinely exposed to cultures of N. meningitidis serogroup B. 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or nursing (breastfeeding) mothers; Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device 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 for at least 60 days prior to study entry; Any serious chronic or progressive disease according to judgment of the investigator; Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria; History of any serogroup B meningococcal vaccine administration; Previous known or suspected disease caused by N. meningitidis; History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine; Known or suspected autoimmune disease or impairment/alteration of the immune system; Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study; History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; Any significant chronic infection; Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time; Family members and household members of research staff; Participation in another clinical trial within the last 30 days or planned for during study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immune response, SBA will be performed against the N. meningitidis serogroup B indicator strains H44/76, NZ98/254 and 5/99 at one month after a vaccination course of two doses of rMenB + OMV NZ administered two months apart.;Secondary Objective: Efficacy Objectives: Characterization of the immune response against vaccine antigen 287-953, as measured by ELISA at one month after a vaccination course of two doses of rMenB + OMV NZ administered two months apart. Safety Objectives: To evaluate the safety and tolerability of two doses of rMenB+OMV NZ vaccine given two months apart, in healthy at-risk adults.;Primary end point(s): Refer to section 7 of the study protocol;Timepoint(s) of evaluation of this end point: Refer to section 3 of the study protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Refer to section 7 of the study protocol;Timepoint(s) of evaluation of this end point: Refer to section 3 of the study protocol | — |
Countries
Germany
Contacts
Public ContactRegulatory Affairs Manager
Novartis Vaccines and Diagnostics GmbH
Outcome results
None listed