Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
NCT ID: NCT01199861
Last Updated: 2012-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
138 participants
INTERVENTIONAL
2010-08-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fingolimod
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.
Fingolimod
Fingolimod 0.5 mg capsules for oral administration.
Seasonal influenza vaccine
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Tetanus toxoid vaccine
Commercially available tetanus toxoid vaccine booster injection.
Placebo
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.
Placebo
Matching placebo capsules for oral administration.
Seasonal influenza vaccine
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Tetanus toxoid vaccine
Commercially available tetanus toxoid vaccine booster injection.
Interventions
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Fingolimod
Fingolimod 0.5 mg capsules for oral administration.
Placebo
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Seasonal influenza vaccine
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Tetanus toxoid vaccine
Commercially available tetanus toxoid vaccine booster injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have lifetime tetanus vaccination
* Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Aalst, , Belgium
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Wilrijk, , Belgium
Novartis Investigative Site
Nepean, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Sherbrooke, , Canada
Novartis Investigative Site
Seinäjoki, , Finland
Novartis Investigative Site
Turku, , Finland
Novartis Investigative Site
Caen, , France
Novartis Investigative Site
Rennes, , France
Novartis Investigative Site
Saint-Herblain, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Katowice, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Seville, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigational Site
Basel, , Switzerland
Novartis Investigative Site
Nottingham, , United Kingdom
Novartis Investigative Site
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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2010-019028-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFTY720D2320
Identifier Type: -
Identifier Source: org_study_id
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