BACTERIAL MENINGITIS. MedDRA version: 17.1 Level: LLT Classification code 10004049 Term: Bacterial meningitis System Organ Class: 100000004862
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. 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 indicating that the subject (and/or parent/legally authorized representative) has been informed of all pertinent aspects of the study. 2. Parent/legally authorized 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 =10 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. Subjects who have received prior HAV vaccination. 4. Contraindication to vaccination with any HAV vaccine. 5. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination. 6. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 7. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 8. 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 SRM for additional details. 9. History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. 10. Significant neurological disorder or history of seizure (excluding simple febrile seizure). 11. Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination. 12. Current chronic use of systemic antibiotics. 13. Current participation in another investigational study. Participation in purely observational studies is acceptable. 14. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination. 15. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 16. 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. 17. Subjects who are investigational site staff members or relatives of those site staff members, or subjects who are Pfizer employees directly involved in the conduct of the trial. 18. Subject is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary Endpoints Five (5) coprimary endpoints are defined for the primary immunogenicity objective based upon results for group 1 subjects in hSBAs performed with each of the 4 primary test strains: PMB80 (A22), PMB2001 (A56), PMB2948 (B24), PMB2707 (B44). ? One (1) of the 5 coprimary 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, 1 month after the third vaccination with bivalent rLP2086 vaccine. ? Four (4) of the coprimary endpoints are defined as the proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1 month after the third vaccination with bivalent rLP2086 vaccine for each of the 4 primary test strains. ? For subjects with a baseline hSBA titer below the limit of detection (LOD or an hSBA titer of < 1:4), a 4-fold response is defined as an hSBA titer of =1:16 or the LLOQ (whichever titer is higher). ? For subjects with a baseline hSBA titer of = LOD (ie, hSBA titer of =1:4) and < lower limit of quantitation (LLOQ), a 4-fold response is defined as an hSBA titer =4 times the LLOQ. ? For subjects with a baseline hSBA titer of = LLOQ, a 4-fold response is defined as an hSBA titer of =4 times the baseline titer. ? The endpoints for the lot consistency objective are hSBA geometric mean titers (GMTs) for each of the 2 primary test strains PMB80 (A22) and PMB2948 (B24) measured 1 month after the third vaccination with bivalent rLP2086 vaccine in group 1, group 2, and group 3. Safety Endpoints ? Percentage of subjects reporting local reactions (pain, redness and swelling) and by severity after each vaccination visit. ? Percentage of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at any injection site, and joint pain) and by severity after each vaccination visit. ? Percentage of subjects repo | — |
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 of study subjects 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 subsets tested with 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, and =1:128 for each of the test strains at baseline and 1 month after the third vaccination with bivalent rLP2086 vaccine. ? hSBA geometric mean titers (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 test 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. For subjects in groups 1, 2, and 3, additional secondary immunogenicity endpoints will include: ? Proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1 month after the second vaccination with bivalent rLP2086 vaccine for each of the 4 primary test strains (group 1) and from baseline to 1 month after the second and third vaccinations with bivalent rLP2086 vaccine for PMB80 (A22) and PMB2948 (B24) (group 2 and group 3), using the following definition | — |
Countries
Canada, Czech Republic, Finland, Germany, Hungary, Italy, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc
Outcome results
None listed