Healthy volunteers (prevention of bacterial meningitis). MedDRA version: 15.1 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
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, 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.Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination. 3.A previous anaphylactic reaction to any vaccine or vaccine-related component. 4.Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine. 5.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6.A known or suspected disease of the immune system or those receiving immunosuppressive therapy. 7.History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. 8.Significant neurological disorder or history of seizure (excluding simple febrile seizure). 9.Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination. 10.Current chronic use of systemic antibiotics. 11.Participation in other studies during study participation. Participation in purely observational studies is acceptable. 12.Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination. 13.Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 14.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. 15.Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. 16.Subject is a direct descendant (e.g. child, grandchild or other family member) of study site or Pfizer personnel. 17.Subject is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the immune response induced by Repevax given with bivalent rLP2086 vaccine (group 1) is non-inferior to the immune response induced by Repevax alone (group 2) when measured 1 month after vaccination 1. The immune responses to all components of Repevax will be assessed.;Secondary Objective: To describe the immune response as measured by hSBA performed with 4 primary MnB test strains, two expressing a LP2086 subfamily A protein and two expressing a LP2086 subfamily B protein, measured 1 month after the third vaccination with bivalent rLP2086 vaccine. Serum samples from approximately 50% of the subjects will have hSBA performed with test strains of LP2086 variants A22 and B24 and the other 50% will be tested with strains of variants A56 and B44.;Primary end point(s): The primary endpoints for this study are the proportions of subjects achieving the prespecified criteria for the concomitant antigens 1 month after vaccination 1.;Timepoint(s) of evaluation of this end point: One month after vaccination 1 in both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): An additional descriptive endpoint for the primary objective is ? The concomitant antigens measured as geometric mean titer (GMT) or geometric mean concentrations (GMCs) at 1-month after vaccination 1 (visit 2). Serum samples from approximately 50% of the subjects will have hSBA performed with test strains of LP2086 variants A22 and B24 and the other 50% will be tested with strains of variants A56 and B44. The hSBA endpoints for the secondary objectives will be considered as secondary endpoints: ? Proportion of subjects with hSBA titer = lower limit of quantitation (LLOQ) at visit 6 (1-month postvaccination 3) for each of the 4 primary MnB test strains.;Timepoint(s) of evaluation of this end point: One month after vaccination 1 in both groups. | — |
Countries
Finland, Germany
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed