Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age

Pfizer

Status and phase

Completed

Phase 4

Conditions

Meningococcal Vaccine

Treatments

Biological: Trumenba

Study type

Interventional

Funder types

Industry

Identifiers

NCT04893811

2018-002588-24 (EudraCT Number)

B1971060

Details and patient eligibility

About

The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.

Enrollment

53 patients

Sex

All

Ages

10+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female participants ≥10 years of age at the time of consent.
Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies.
Negative urine pregnancy test for all female participants.

Exclusion criteria

Previous vaccination with any meningococcal serogroup B vaccine.
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.
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Any confirmed or suspected human immunodeficiency virus infection.
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.
Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment.
Current chronic use of systemic antibiotics.
Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab).
Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.