A study in young adults to see if 3 doses of Mn B vaccine works

Update Il y a 4 ans
Reference: EUCTR2009-014492-46

Woman and Man

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Extract

Primary Objectives  To assess the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with 4 primary MnB test strains, two expressing a LP2086 subfamily A protein and two expressing a LP2086 subfamily B protein, measured 1 month after the third vaccination with bivalent rLP2086 vaccine. Primary Safety Objective  To evaluate the safety profile of bivalent rLP2086 vaccine compared to a control (saline), as measured by local reactions, systemic events, AEs, SAEs, newly-diagnosed chronic medical conditions, medically attended adverse events, and immediate AEs.


Inclusion criteria

  • Pfizer?s investigational bivalent rLP2086 vaccine is being developed for prevention of invasive meningococcal disease caused by N meningitidis serogroup B