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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Fingolimod Hydrochloride; Vaccines

Criteria

Inclusion Criteria:

• Must have relapsing MS

• Must have lifetime tetanus vaccination

• Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection

Exclusion Criteria:

• Patients with a type of MS that is not relapsing

• Patients with history of chronic immune disease

• Certain cancers

• Diabetic patients with certain eye disorders

• Patients who are on certain immunosuppressive medications or heart medications

• Patients with certain heart conditions

• Patients with certain lung conditions

• Patients who have already received the 2010/2011 seasonal influenza vaccine

Other protocol-defined inclusion/exclusion criteria may apply