Study to Assess the Immunogenicity and Safety of GSK's Meningococcal Group B Vaccine When Administered Concomitantly with GSK's Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
The purpose of this study is to evaluate the
immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines
when concomitantly administered to healthy subjects 16-18 years of age.
As per the recommendation from Center for Biologics Evaluation and
Research (CBER) the study has been amended to include a new
"agar-overlay" serum bactericidal assay using human serum complement
(hSBA). Additional changes include validation of the MenB manual to measure
immunogenicity of the meningococcal group B vaccine, a modification in the
definition of 4-fold increase in post-vaccination hSBA titer definition when
the pre-vaccination titer is below the limit of detection, and a modification
in the population set to be used for safety analysis wherein the exposed set is
to be used for all safety analyses.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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