Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Relapsing Multiple Sclerosis

Eligibility:

All Genders

18-55 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • Must have relapsing MS
  • Must have lifetime tetanus vaccination
  • Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2011

Estimated Enrollment :

138 Patients enrolled

Trial Details

Trial ID

NCT01199861

Start Date

August 1 2010

End Date

May 1 2011

Last Update

June 19 2012

Active Locations (25)

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Page 1 of 7 (25 locations)

1

Novartis Investigative Site

Aalst, Belgium, 9300

2

Novartis Investigative Site

Brussels, Belgium, 1200

3

Novartis Investigative Site

Leuven, Belgium, 3000

4

Novartis Investigative Site

Liège, Belgium, 4000