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SPLEMENGO - Multicenter, randomized, phase III, trial assessing the immunogenicity and safety of three meningococal B vaccine strategies among patients with asplenia
EU CTIS ID: 2024-513649-35-00
What this study is testing
The primary objective of this trial is to assess immunogenicity one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms), in asplenic adults.
- Therapeutic confirmatory (Phase III)
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
- Male or female, >=18 to <=75 years old
- Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
- Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
- Women of childbearing age must have an effective contraception during the first 9 months of the study.
- Participants must give written consent prior to any trial procedure.
- Participants must be covered by social security regimen or equivalent.
You likely can't join if
- History of meningococcal B vaccination.
- Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.
- Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.
- Severe acute febrile illness within the week before inclusion
- Registration for any other clinical trial throughout the trial period except observational study.
- History of anaphylaxis post vaccination.
See the full eligibility criteria
- Male or female, >=18 to <=75 years old
- Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
- Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
- Women of childbearing age must have an effective contraception during the first 9 months of the study.
- Participants must give written consent prior to any trial procedure.
- Participants must be covered by social security regimen or equivalent.
- Participants will be followed during the 4 years from the inclusion visit.
- History of meningococcal B vaccination.
- Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.
- Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.
- Severe acute febrile illness within the week before inclusion
- Registration for any other clinical trial throughout the trial period except observational study.
- History of anaphylaxis post vaccination.
- Known allergy to any components (active substances or excipients) of both vaccines.
- Patients who cannot stop antibiotics 3 days before blood collection.
- Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 7 months of the study (excepted meningocoque ACWY vaccine, pneumococcal vaccine, Haemophilus vaccine, Covid-19 vaccine and annual influenza vaccination which is permitted 2 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).
- Parenteral Ig within the 3 months prior to VS or planned during the study.
- Chemotherapy agents within 6 months prior M0 or planning to take any during the study.
- Steroids (> 10mg/day; > 14 days) within the month preceding M0 or planning to take any during the study.
- Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, evolutive cancer, cirrhosis, known infection to HIV;
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, 65+ 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.