Overview

Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Sanofi
Treatments:
Interferon beta-1b
Interferon-beta
Interferons
Teriflunomide
Vaccines