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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
128
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
Investigational Site Number 040001
Vienna, Austria
Investigational Site Number 124005
Calgary, Canada
Investigational Site Number 124003
Greenfield Park, Canada
Investigational Site Number 124002
London, Canada
Investigational Site Number 124007
Montreal, Canada
Investigational Site Number 124008
Ottawa, Canada
Investigational Site Number 124001
Québec, Canada
Investigational Site Number 124009
Toronto, Canada
Investigational Site Number 276003
Berlin, Germany
Investigational Site Number 276001
Essen, Germany
...and 4 more locations
Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination
For each viral strain (H1N1, H3N2, and B), the antibody titer, level of antibodies in blood sample when exposed to antigen, was calculated as the mean of two replicates. If the titer was below or above the limit of detection, the threshold value was used. The percentage of participants achieving a titer of 40 or more, as well as the 90% confidence interval (CI) using normal approximation were calculated for each strain and treatment group.
Time frame: 28 days post vaccination
Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination
Percentages of participants with an increase from baseline of 2-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.
Time frame: pre vaccination (baseline) and 28 days post vaccination
Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination
Percentages of participants with an increase from baseline of 4-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.
Time frame: pre vaccination (baseline) and 28 days post vaccination
Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination
Time frame: pre vaccination (baseline) and 28 days post vaccination
Immunoglobulin Levels
Time frame: pre vaccination (baseline) and 28 days post vaccination
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