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Recruiting Phase 3 NCT04166656

Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.

Trial Parameters

Condition Splenectomy
Sponsor Assistance Publique - Hôpitaux de Paris
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 84
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-09-15
Completion 2028-09
Interventions
Trumenba®Bexsero®

Brief Summary

The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.

Eligibility Criteria

Inclusion Criteria: 1. Male or female, \>=18 to \<=75 years old. 2. Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film 3. Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up 4. Women of childbearing age must have an effective contraception during the first 9 months of the study. 5. Participants must give written consent prior to any trial procedure 6. Participants must be covered by social security regimen or equivalent. 7. Participants will be followed during the 4 years from the inclusion visit. Exclusion Criteria: 1. History of meningococcal vaccination B. 2. History of anaphylaxis post vaccination. 3. Known allergy to any components (active substances or excipients) of both vaccines. 4. Patients who cannot stop antibiotics 3 days before blood collection. 5. Participants who have received any another vaccines within 4 weeks prior to immunization or who are plan

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