Conditions: Multiple Sclerosis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: no

Brief 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.

Detailed description:
The maximum duration of the study period for a participant was approximatively 49 days broken down as follows:

* Screening period of up to 21 days;
* Influenza vaccination at Day 1;
* Follow-up period of 28 days (±2 days).

MS treatment (Teriflunomide or interferon-β-1) was to be continued during the course of the study.

Arms:
arm 1: Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months arm 2: Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months arm 3: Influenza vaccine in participants treated with a stable dose of Interferon-β-1 (IFN-β-1) for at least 6 months

Interventions: intervention 1: teriflunomide intervention 2: Interferon-β-1 intervention 3: Influenza vaccine
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration intervention 2: Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection intervention 3: Inactivated, split-virion influenza vaccine 2011-2012

One administration by intramuscular or intradermal route as per product specification

Protocol document: