At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
In Brief
A Phase 2 clinical trial evaluating Meningococcal ABCWY and Placebo for Meningococcal Disease. Completed, enrolled 189 participants across 8 sites.
Detailed Summary
This is extension of the V102\_16 study (NCT02140762). V102\_16E1 is designed to assess the effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6 month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as measured by enc-hSBA assay. The subjects who completed the parent V102\_16 study will be invited at the time of their last study visit to participate in this extension study.
Study Details
Timeline
Interventions
One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)