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
Conditions
Interventions
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 descr
Sponsors
Pfizer Inc 235 East 42nd Street, New York, NY10017
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1.Previous vaccination with any meningococcal serogroup B vaccine. 2.A previous anaphylactic reaction to any vaccine or vaccine-related component. 3.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 4.A known or suspected disease of the immune system or those receiving immunosuppressive therapy. 5.History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. 6.Significant neurological disorder or history of seizure (excluding simple febrile seizure). 7.Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination. 8.Current chronic use of systemic antibiotics. 9.Participation in other studies during study participation. Participation in purely observational studies is acceptable. 10.Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination. 11.Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 12.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 13.Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. 14.Subject is a direct descendant (e.g., child, grandchild or other family member) of study site or Pfizer personnel. 15.Subject is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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). ;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.;Timepoint(s) of evaluation of this end point: One month after the third dose of bivalent rLP2086 (Groups 1 and 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Protocol 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. | — |
Countries
Czech Republic, Denmark, Finland, Germany, Poland, Spain, Sweden
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed