At a glance
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A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.
In Brief
A Phase 3 clinical trial evaluating No Vaccine and rMenB+OMV-NZ for Meningococcal Disease and Meningococcal Meningitis. Completed, enrolled 817 participants across 6 sites.
Detailed Summary
This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713). Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined as subjects who had never received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who were eligible to participate in this extension study, performed one study visit in which a single blood sample was drawn for MenB serological analyses.
Study Details
Timeline
Interventions
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).