Status:
COMPLETED
Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
Lead Sponsor:
Pfizer
Conditions:
Meningococcal Vaccine
Eligibility:
All Genders
10+ years
Phase:
PHASE4
Brief Summary
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04893811
Start Date
August 18 2021
End Date
September 6 2023
Last Update
October 16 2024
Active Locations (14)
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1
Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
Brno, Czechia, 613 00
2
Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
Brno, Czechia, 61300
3
Fakultni nemocnice v Motole
Prague, Czechia, 150 06
4
IN-VIVO Sp. z o.o.
Bydgoszcz, Poland, 85-048