prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B MedDRA version: 20.0 Level: LLT Classification code 10027276 Term: Meningococcal meningitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Trumenba
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Neisseria meningitidis serogroup B fHbp subfamily A
Other descriptive name: NEISSERIA MENI
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age and Sex: 1. Male or female participants =10 years of age at the time of consent. Type of Participant and Disease Characteristics: 2. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies (including but not limited to C5-C9, properdin, factor H, or factor D). 4. Available for the entire study period and can be reached by telephone. 5. Female participants of childbearing potential must agree to use a highly effective method of contraception through at least 28 days after the last study vaccination. A participant is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active. This criterion is not applicable to male participants. 6. Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants. Informed Consent: 7. Participants who are, or whose parent(s)/legal guardian(s) are, capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical Conditions: 1. A previous anaphylactic reaction to any vaccine or vaccine-related component. 2. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 3. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae. 4. Significant neurological disorder or history of seizure (excluding simple febrile seizure). 5. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 6. Any confirmed or suspected human immunodeficiency virus infection, based on medical history and physical examination (no laboratory testing required). 7. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. Prior/Concomitant Therapy: 8. Previous vaccination with any meningococcal serogroup B vaccine. 9. Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 10. Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment. 11. Current chronic use of systemic antibiotics. 12. Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab). Prior/Concurrent Clinical Study Experience: 13. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Other Exclusions: 14. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. 15. Pregnant female participants; breastfeeding female participants; female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Immunogenicity: To describe the immune response induced by 2 doses of Trumenba in immunocompromised participants and historical age-matched healthy participants as measured by hSBA performed with 4 primary MnB test strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein. Primary Safety: To evaluate the safety profile of Trumenba in immunocompromised participants and historical age matched healthy participants.;Secondary Objective: not applicable;Primary end point(s): Primary Immunogenicity: • hSBA titer for each of the primary MenB test strains (A22, A56, B24, and B44). Primary Safety: • Local reactions (pain at the injection site, redness, and swelling). • Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain). • Use of antipyretic medication. • AEs. • SAEs. • MAEs. • Immediate AEs. • NDCMCs. • Days missing from school or work because of AEs. ;Timepoint(s) of evaluation of this end point: Timepoints as outlined in the Schedule of Activities of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Czechia, Czech Republic, Poland, Türkiye, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed