CompletedPhase 4

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

Czechia, Poland53 participantsStarted 2021-08-18

Plain-language 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 antibody production in asplenic and complement-deficient individuals ≥10 years of age.

Who can participate

Age range10 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, r…

What they're measuring

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer => Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains at Baseline

Timeframe: Baseline (Before Vaccination 1 on Day 1/Month 0)

Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2

Timeframe: 1 Month after Vaccination 2 (Vaccination 2 at Month 6)

Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1

Timeframe: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2

Timeframe: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1

Timeframe: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2

Timeframe: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

Trial details

NCT IDNCT04893811

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-06

Results submitted2024-07-15

View on ClinicalTrials.gov More Meningococcal Vaccine trials