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

NCT04893811

CompletedPhase 4

Sponsor: Pfizer

Conditions: Meningococcal Vaccine

Interventions: Trumenba

Countries: Czechia, Poland, Turkey (Türkiye)

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.

Eligibility overview

Sex: ALL

Age: 10 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (14)
  • Brno, Czechia
  • Brno, Czechia
  • Prague, Czechia
  • Bydgoszcz, Poland
  • Krakow, Poland
  • Warsaw, Poland
  • Warsaw, Poland
  • Adana, Yüreği̇r, Turkey (Türkiye)
  • Adana, Yüreği̇r, Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
  • Mersin, Turkey (Türkiye)