Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
NCT ID: NCT04893811
Last Updated: 2024-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
53 participants
INTERVENTIONAL
2021-08-18
2023-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Single Arm
Bivalent recombinant lipoprotein 2086 vaccine
Trumenba
Bivalent recombinant lipoprotein 2086 vaccine
Interventions
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Trumenba
Bivalent recombinant lipoprotein 2086 vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
Brno, , Czechia
Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
Brno, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
IN-VIVO Sp. z o.o.
Bydgoszcz, , Poland
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
Warsaw, , Poland
Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
Adana, Yüreği̇r, Turkey (Türkiye)
Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
Adana, Yüreği̇r, Turkey (Türkiye)
Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
Adana, , Turkey (Türkiye)
Acibadem Adana Hastanesi
Adana, , Turkey (Türkiye)
Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-002588-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1971060
Identifier Type: -
Identifier Source: org_study_id
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