CompletedPhase 4

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

Czechia, Poland, Turkey (Türkiye)53 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 range

10 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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