NCT01199861

Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)

A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fingolimod	Fingolimod 0.5 mg capsules for oral administration.
DRUG	Placebo	Matching placebo capsules for oral administration.
BIOLOGICAL	Seasonal influenza vaccine	Commercially available injectable influenza vaccine for the 2010/11 influenza season.
BIOLOGICAL	Tetanus toxoid vaccine	Commercially available tetanus toxoid vaccine booster injection.

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-09-13
• Last updated: 2012-06-19
• Results posted: 2012-06-19

Locations

25 sites across 9 countries: Belgium, Canada, Finland, France, Guatemala, Poland, Spain, Switzerland, United Kingdom