At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference
In Brief
A Phase 2 clinical trial evaluating teriflunomide, Interferon-β-1, and 1 other intervention for Multiple Sclerosis. Completed, enrolled 128 participants across 14 sites in 5 countries.
Detailed Summary
Primary Objective: Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population. Secondary Objectives: * Assess the effect of teriflunomide on immunoglobulin levels; * Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide. The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.
Study Details
Timeline
Interventions
Film-coated tablet Oral administration
Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
Inactivated, split-virion influenza vaccine 2011-2012 One administration by intramuscular or intradermal route as per product specification