Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years. MedDRA version: 14.1 Level: LLT Classification code 10004049 Term: Bacterial meningitis System Organ Class: 100000004862
Conditions
Sponsors
Pfizer Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study. 2. Parent/legally authorized representative and 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: 1. Previous vaccination with any meningococcal serogroup B vaccine. 2. Previous vaccination with any HPV vaccine. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Contraindication to vaccination with Gardasil® or any HPV vaccine. 5. 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. 6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 7. 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 with terminal complement deficiency may not be included. 8. History of any sexually transmitted disease. 9. History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea. 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. Participation in other studies during study participation. Participation in purely observational studies is acceptable. 14. Received any investigational drugs, vaccines 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 who are Pfizer employees directly involved in the conduct of the trial or relatives of those Pfizer employees. 18. Subject is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the immune response (based on geometric mean titer [GMT]) induced by Gardasil given with bivalent rLP2086 vaccine (Group1) is noninferior to the immune response induced by Gardasil alone (Group3) as measured 1month after the 3rd vaccination (Visit5) with Gardasil in both groups. The immune response to all 4 components of Gardasil will be assessed To demonstrate the immune response (based on GMT) induced by bivalent rLP2086 vaccine given with Gardasil (Group1) is noninferior to the immune response induced by bivalent rLP2086 vaccine alone (Group2) as measured by serum bactericidal assay using human complement performed with 2 MnB test strains, 1 expressing LP2086 subfamily A and 1 expressing LP2086 subfamily B proteins, when measured 1 month after the third vaccination (Visit5) with bivalent rLP2086 vaccine in both groups To evaluate the safety profile of bivalent rLP2086 vaccine as measured by proportion of subjects reporting local reactions, systemic events and AEs;Secondary Objective: To describe the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with 4 MnB test strains, 2 expressing LP2086 subfamily A and 2 expressing LP2086 subfamily B proteins, measured 1 month after the third vaccination (Visit 5) with bivalent rLP2086 vaccine (Group 2) To describe the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with 4 MnB test strains, 2 expressing LP2086 subfamily A and 2 expressing LP2086 subfamily B proteins, measured 1 month after the second vaccination (Visit 3) with bivalent rLP2086 vaccine (Group 2) To demonstrate that the immune response induced by Gardasil given with bivalent rLP2086 vaccine (Group 1) as measured by seroconversion, is non-inferior to the immune response induced by Gardasil® alone (Group 3) when measured 1 month after the third vaccination (Visit 5) with Gardasil® in both groups. The immune response to all 4 serotypes | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The seroconversion rate for each of the 4 HPV antigens, 1 month after the third vaccination (Visit 5) of Gardasil® for subjects with baseline seronegative in Groups 1 and 3. The seroconversion rate is defined as anti HPV serum competitive Luminex® immunoassay (cLIA) levels =20 mMU/mL for HPV 6, =16 mMU/mL for HPV 11, =20 mMU/mL for HPV 16, and =24 mMU/mL for HPV 18. A subject having anti HPV serum cLIA levels less than these cutoff points at Visit 1 will be considered baseline seronegative; a subject having anti HPV serum cLIA levels greater than or equal to these cutoff points at Visit 1 will be considered baseline seropositive • Proportion of subjects with baseline seropositive for each of the 4 HPV antigens. • Proportion of subjects with hSBA titers = lower limit of quantitation (LLOQ), =1:4, =1:8, =1:16, =1:32, =1:64, =1:128 for each of the 4 primary strains (PMB80 [A22], PMB2001 [A56], PMB2948 [B24], PMB2707 [B44]) at each applicable blood draw time point. • hSBA geometric mean titers (GMTs) for each of the 4 primary strains (PMB80 [A22], PMB2001 [A56], PMB2948 [B24], PMB2707 [B44]) at each applicable blood sampling time point ;Timepoint(s) of evaluation of this end point: • One month after third vaccination • Pre-bleed at visit 1 • One month after second and third vaccination • One month after second and third vaccination | — |
Countries
United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed