Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing multiple sclerosis MS Immune response
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 138
Healthy volunteers: no

Brief summary:
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.

Detailed description:

Arms:
arm 1: Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. arm 2: Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.

Interventions: intervention 1: Fingolimod intervention 2: Placebo intervention 3: Seasonal influenza vaccine intervention 4: Tetanus toxoid vaccine
Intervention descriptions: intervention 1: Fingolimod 0.5 mg capsules for oral administration. intervention 2: Matching placebo capsules for oral administration. intervention 3: Commercially available injectable influenza vaccine for the 2010/11 influenza season. intervention 4: Commercially available tetanus toxoid vaccine booster injection.

Protocol document: