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Clinical Trial 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.


Clinical Trial Description

Currently, in France, no immunogenicity data on Meningococcal B vaccines, neither with Bexsero® nor with Trumenba®, are available in asplenic patients, population at high risk of infection. As asplenic individuals (all causes) show less optimal immune response to conjugate meningococcal C vaccine compared to matched controls. [4], we hypothesize that a similar less optimal response may be expected for MenB vaccines among asplenic subjects. . That is why, we proposed in this study to evaluate two reinforced strategies with 3 administrations (M0, M1, and M6) of Bexsero® or Trumenba ®. Moreover, the study will also allow exploring the persistence of the immune response in this population. Indeed, few data are available on this persistence in the general population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04166656
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Odile LAUNAY, MD,PhD
Phone +33(01)58 41 28 58
Email odile.launay@aphp.fr
Status Recruiting
Phase Phase 3
Start date September 15, 2022
Completion date October 2028

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