Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
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.
Age
18–59
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\- Male or female patient \<60 years old with relapsing multiple sclerosis (RMS) either treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048 or LTS6050, or treated with a stable dose of interferon-β-1 for at least 6 months.
You may not be if
Concomitant infectious pathology at the time of vaccination;
MS relapse within 1 month before vaccination;
Systemic corticosteroids within 1 month before the vaccination;
Any contraindication to influenza vaccine;
Any vaccination within the last 6 months;
Prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon-β-1);
Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri®), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development;
Prior or concomitant use of glatiramer acetate within 1 year before study entry;
Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry;
Pregnant or breast feeding women;
Woman of childbearing potential without adequate contraception.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
