A clinical trial to determine if the investigational MnB vaccine works the same every time a batch (or lot) of the vaccine is made

Update Il y a 4 ans
Reference: EUCTR2010-023873-20

Woman and Man

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Extract

Co-Primary  To demonstrate that the immune response induced by 3 lots of rLP2086 vaccine are equivalent as measured by serum bactericidal assay using human complement (hSBA) performed with MnB strains expressing LP2086 subfamily A and B proteins, 1 month after study vaccination 3.  To assess the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after study vaccination 3 in a subset of subjects in group 1. Primary Safety  To evaluate the safety profile of 3 lots of rLP2086 vaccine as measured by the proportion of subjects reporting local reactions, systemic events and adverse events (AEs).


Inclusion criteria

  • bacterial meningitis