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

Recruiting Phase 3 Interventional Study
Splenectomy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
84 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial

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.

Trial Locations
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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…
Contacts

Odile LAUNAY, MD,PhD

+33(01)58 41 28 58

odile.launay@aphp.fr

CONTACT

Audrey BECLIN-CLABAUX

+33 (0)1 58 41 33 82

audrey.clabaux@aphp.fr

CONTACT