A clinical trial to determine if the investigational MnB vaccine works when 2 or 3 doses of the vaccine is given to adolescents

INTERVENTION: Product Name: MnB rLP2086 Product Code: Not Applicable Pharmaceutical Form: Suspension for injection INN or Proposed INN: MnB rLP2086 subfamily A CAS Number: n/a Current Sponsor code: n/a Other descriptive name: n/a Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 120‐ INN or Proposed INN: MnB rLP2086 subfamily B CAS Number: n/a Current Sponsor code: n/a Other descriptive name: n/a Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 120‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Healthy volunteers (prevention of bacterial meningitis). ; MedDRA version: 14.1 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: Co‐Primary Objectives:; ; To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the third vaccination with bivalent rLP2086 vaccine among group 1 subjects.; ; To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the third vaccination with bivalent rLP2086 vaccine among group 2 subjects.; ; Primary end point(s): The primary endpoint for the first co‐primary objectives are the proportion of subjects achieving hSBA titer = lower limit of quantitation (LLOQ), for each of the 4 primary strains, measured 1 month after the third vaccination with bivalent rLP2086 vaccine (as measured at visit 6) among group 1 subjects.; ; The primary endpoint for the second co‐primary objectives are the; proportion of subjects achieving hSBA titer = LLOQ, for each of the 4 primary strains, measured 1 month after the third vaccination with bivalent rLP2086 vaccine (visit 6) among group 2 subjects.). Secondary Objective: To assess the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after the second vaccination with bivalent rLP2086 vaccine among group 3 subjects.; ; To describe the immune response as measured by serum bactericidal assay performed with MnB strains expressing LP2086 subfamily A and B proteins, throughout the study (all groups). Timepoint(s) of evaluation of this end point: One month after the third dose of bivalent rLP2086 (Groups 1 and 2). SECONDARY OUTCOME: Secondary end point(s): The endpoint for the first of the secondary objectives is the ; proportion of subjects achieving hSBA titer = LLOQ, for each of the 4 primary strains, measured 1 month after the second vaccination with bivalent rLP2086 vaccine among group 3 subjects. ; ; The testing strategy for the above hypothesis testing endpoints is described in Section 9.5. ; Additional secondary endpoints for descriptive purposes include the following: ; 1.hSBA geometric mean titers (GMT) for each of the 4 primary strains at each blood sampling time point; ; 2.Proportion of subjects with hSBA titer = LLOQ, for each of the 4 primary strains, at each blood sampling time point; ; 3. Proportions of subjects with hSBA titers =1:4, =1:8, =1:16, =1:32, =1:64, = 1:128 at each blood sampling time point. ; Timepoint(s) of evaluation of this end point: One month after the second dose of bivalent rLP2086 (group 3) and at other timepoints detailed in E 5.2. INCLUSION CRITERIA: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. 1.Evidence of a personally signed and dated informed consent document (ICD) indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study. 2.Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3.Male or female subject aged =11 and <19 years at the time of enrollment. 4.Available for the entire study period and can be reached by telephone. 5.Healthy subject as determined by medical history, physical examination, and judgment of the investigator. 6.All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus sperm