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 =10 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. Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination. 3. Previous vaccination with any MCV4 vaccine. 4. A previous anaphylactic reaction to any vaccine or vaccine-related component. 5. Contraindication to vaccination with MCV4 and/or Tdap vaccine. 6. 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. 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 with terminal complement deficiency may not be included. 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: demonstrate immune response(based on geometric mean titer GMT)induced by MCV4 and Tdap vaccines given with bivalent rLP2086 vaccine(Group1)is noninferior to immune response induced by MCV4 and Tdap vaccines alone(Group2)when measured 1month after first vaccination(Visit2)in both groups. Immune response to all components of MCV4 and Tdap vaccines will be assessed. demonstrate immune response (based on GMT)induced by bivalent rLP2086 vaccine,as measured by serum bactericidal assay using human complement(hSBA)performed with 2MnB strains, 1expressing LP2086 subfamily A and 1expressing LP2086 subfamily B proteins,given with MCV4 and Tdap vaccines(Group1)is noninferior to the immune response induced by bivalent rLP2086 vaccine alone(Group3),when measured 1month after the third vaccination(Visit6)with bivalent rLP2086 vaccine in both groups evaluate safety profile of bivalent rLP2086 vaccine as measured by proportion of subjects reporting local reactions,systemic events,adverse events ;Secondary Objective: To describe the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with 2 MnB strains, one expressing LP2086 subfamily A and one expressing LP2086 subfamily B proteins, measured 1 month after the third vaccination (Visit 6) with bivalent rLP2086 vaccine (Group 3). To describe the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with 2 MnB strains, one expressing LP2086 subfamily A and one expressing LP2086 subfamily B proteins, measured 1 month after the second vaccination (Visit 4) with bivalent rLP2086 vaccine (Group 3) To describe the seroresponses to antigens contained in MCV4 and Tdap (Groups 1 and 2) when measured 1 month after vaccination with MCV4 and Tdap (Visit 2) ;Primary end point(s): The primary endpoints for the co-primary objectives are: The primary endpoints for the first co-primary objective are the geometric mean titers (GMTs) or geometric mean | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The seroresponse rate at visit 2 for each of the 10 marketed vaccine antigens in Group 1 and Group 2. • For Tdap vaccine, the booster response is used, which is defined as at least 4-fold rise in antibody concentration if the pre-vaccination concentration is = cutoff value and at least 2-fold rise in antibody concentration if the pre-vaccination concentration is > cutoff value. The cutoff values are described as below: Table 1. Cutoff for Booster Response Antigens : Cutoff Tdap Diphtheria : 0.1 IU/mL Tetanus : 0.1 IU/mL Pertussis toxoid (PT) : 0.9 EU/mL Pertussis filamentous hemagglutinin (FHA) : 2.9 EU/mL Pertussis pertactin (PRN) : 3.0 EU/mL Pertussis fimbriae types 2 and 3 (FIM) : 10.6 EU/mL • For MCV4, the seroconversion rate is used, which is defined as =4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers • Proportion of subjects (Groups 1 and 2) who achieve an antibody level =1.0 IU/mL to tetanus and proportion of subjects (Groups 1 and 2) who achieve an antibody level =1.0 IU/mL to diphtheria toxoid • hSBA titers as measured by GMTs for each of the 2 primary MnB test strains (PMB80 [A22] and PMB2948 [B24]) at each applicable blood sampling time point • Proportion of subjects with hSBA titers =LLOQ, =1:4, =1:8, =1:16 , =1:32, =1:64, =1:128 at each blood draw visit, for each of the 2 primary strains (PMB80 [A22] and PMB2948 [B24]) ;Timepoint(s) of evaluation of this end point: • One month after vaccination 1. • One month after vaccination 1. • One month after vaccination 1. • One month after first, second, and third vaccination. • One month after first, second, and third vaccination | — |
Countries
United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed