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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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