At a glance
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A Phase IV, Open-label, Controlled, Multi-center Study to Evaluate the 5-year Antibody Persistence Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine at 2 to 10 Years of Age and to Assess the Immune Response to a Single Dose of Novartis MenACWY Conjugate Vaccine
In Brief
A Phase 4 clinical trial evaluating Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine for Meningococcal Disease. Completed, enrolled 465 participants across 16 sites in 2 countries.
Detailed Summary
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).
Study Details
Timeline
Interventions
Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.