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Meningococcal B vaccine in patients with asplenia
EU CTIS ID: 2023-508192-36-00
What this study is testing
To demonstrate that the immunogenicity of the meningococcal serogroup B vaccine BEXSERO® is non-inferior in asplenic patients compared to a healthy control group, measured by human serum bactericidal antibody assay one month after second vaccination.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- asplenia due to splenectomy or functional asplenia (only patients)
- 18 to 60 years of age
- if female: have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
- providing written informed consent
You likely can't join if
- previous vaccination against meningococcal serogroup B
- pregnant or lactating
- febrile illness within last two weeks prior to enrolment
- allergic reactions to vaccination in past
- chemotherapy with Rituximab within last six months or during study period (only patients)
- more than 20mg prednisone per day within last four weeks prior or at the time of enrolment (only patients)
See the full eligibility criteria
- asplenia due to splenectomy or functional asplenia (only patients)
- 18 to 60 years of age
- if female: have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
- providing written informed consent
- previous vaccination against meningococcal serogroup B
- pregnant or lactating
- febrile illness within last two weeks prior to enrolment
- allergic reactions to vaccination in past
- chemotherapy with Rituximab within last six months or during study period (only patients)
- more than 20mg prednisone per day within last four weeks prior or at the time of enrolment (only patients)
- any immunosuppressive condition or medication (only healthy controls)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.