Extract

To demonstrate the immune response (based on geometric mean titer [GMT]) induced by Gardasil given with bivalent rLP2086 vaccine (Group1) is noninferior to the immune response induced by Gardasil alone (Group3) as measured 1month after the 3rd vaccination (Visit5) with Gardasil in both groups. The immune response to all 4 components of Gardasil will be assessed To demonstrate the immune response (based on GMT) induced by bivalent rLP2086 vaccine given with Gardasil (Group1) is noninferior to the immune response induced by bivalent rLP2086 vaccine alone (Group2) as measured by serum bactericidal assay using human complement performed with 2 MnB test strains, 1 expressing LP2086 subfamily A and 1 expressing LP2086 subfamily B proteins, when measured 1 month after the third vaccination (Visit5) with bivalent rLP2086 vaccine in both groups To evaluate the safety profile of bivalent rLP2086 vaccine as measured by proportion of subjects reporting local reactions, systemic events and AEs

Inclusion criteria

• Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years

Links

• euctr