Pfizer‘s investigational bivalent rLP2086 vaccine is being developed for prevention of invasive meningococcal disease caused by N meningitidis serogroup B. MedDRA version: 14.1 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS System Organ Class: 100000004862
Conditions
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures. 3. Male or female subject aged =18 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. Subjects who are scheduled to receive one or more doses of an human papilloma virus (HPV) vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second study vaccination. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study. Please refer to the study reference manual (SRM) additional details. 7. History of microbiologically-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. Current participation in another investigational study. Participation in purely observational studies is acceptable. 12. Received any investigational vaccines, 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 relatives of those site staff members or who are Pfizer employees directly involved in the conduct of the trial or relatives of those Pfizer employees. 16. Subject is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives ? To assess the immune response as measured by serum bactericidal assay using human complement (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. Primary Safety Objective ? To evaluate the safety profile of bivalent rLP2086 vaccine compared to a control (saline), as measured by local reactions, systemic events, AEs, SAEs, newly-diagnosed chronic medical conditions, medically attended adverse events, and immediate AEs.;Secondary Objective: ? To describe the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with 10 secondary MnB test strains expressing LP2086 subfamily A or B proteins measured 1 month after the third vaccination with bivalent rLP2086 vaccine. ? To describe the immune response as measured by serum bactericidal assay using human complement (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 second vaccination with bivalent rLP2086 vaccine.;Timepoint(s) of evaluation of this end point: No interim analysis is planned for this study. Only one final analysis will be performed on the final locked study database and will include all of the immunogenicity and safety analysis results related to the primary and secondary objectives;Primary end point(s): Primary Endpoint Five (5) co-primary endpoints are defined for the Primary Immunogenicity objective based upon results for group 1 subjects in hSBA performed with each of the 4 primary test strains: PMB80 (A22), PMB2001 (A56), PMB2948 (B24), PMB2707(B44). ? One of the 5 co-primary endpoints is the composite endpoint defined as the proportion of subjects achieving an hSBA titer = lower limit of quantitation (LLOQ) for all 4 primary test strains combined | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary strain immunogenicity objective is based on hSBA results from subjects in group 1 using 10 test strains expressing the following variants: A29, A06, A12, A07, A15, A19, B16, B09, B03, B15. Three (3) subsets will be selected for this analysis. Each subset will be used to assess the response to 3 or 4 of the 10 secondary test strains in addition to the 4 primary test strains. The secondary immunogenicity endpoints for the secondary hSBA test strains are: ? Proportions of subjects with hSBA titers = LLOQ for each of the test strains at baseline and 1 month after the third vaccination with bivalent rLP2086 vaccine. ? Proportions of subjects with hSBA titers =1:4, =1:8, =1:16, =1:32, =1:64, =1:128 for each of the test strains at baseline and 1 month after the third vaccination with bivalent rLP2086 vaccine. ? hSBA GMTs for each of the test strains at baseline and 1 month after the third vaccination with bivalent rLP2086 vaccine. For group 1 subjects, additional secondary immunogenicity endpoints will include: ? Proportion of subjects with a composite hSBA response, defined as subjects with an hSBA titer of = LLOQ for all 4 primary strains, at baseline. ? Proportion of subjects achieving a composite hSBA response defined as subjects achieving an hSBA titer of = LLOQ for all 4 primary test strains, at 1 month after the second vaccination with bivalent rLP2086 vaccine. ? Proportion of subjects achieving at least a 4-fold increase from baseline to one month after the second vaccination with bivalent rLP2086 vaccine for each of the 4 primary test strains using the following definition: ? For subjects with a baseline hSBA titer below the LOD or a hSBA titer of < (1:4), a 4-fold response is defined as hSBA titer of = 1:16 or the LLOQ (whichever titer is higher). ? For subjects with a baseline hSBA titer of = LOD (i.e, hSBA titer of =1:4) and < LLOQ, a 4-fold response is defined as an hSBA titer = four times the LLOQ. | — |
Countries
Canada, Denmark, Finland, Germany, Poland, Spain, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed