Meningococcal B vaccine in patients with asplenia

Phase 1

Recruiting

• Conditions: Splenectomy; MedDRA version: 20.0Level: PTClassification code: 10041642Term: Splenectomy Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-508192-36-00
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion 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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified