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)
2 other identifiers
interventional
138
9 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2010
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 9, 2010
CompletedFirst Posted
Study publicly available on registry
September 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
June 19, 2012
CompletedJune 19, 2012
May 1, 2012
9 months
September 9, 2010
May 15, 2012
May 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immune Response 3 Weeks After Seasonal Influenza Vaccination
Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine: * Seroconversion: The pre-vaccination antibody titer measurement was \<1:10 and the post-vaccination measurement is ≥1:40. * Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.
Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)
Secondary Outcomes (6)
Immune Response 6 Weeks After Seasonal Influenza Vaccination
Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).
Immune Response 3 Weeks After Tetanus Toxoid Booster
Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)
Immune Response 6 Weeks After Tetanus Toxoid Booster
Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)
Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination
Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).
Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination
Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).
- +1 more secondary outcomes
Study Arms (2)
Fingolimod
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Commercially available tetanus toxoid vaccine booster injection.
Eligibility Criteria
You may qualify if:
- Must have relapsing MS
- Must have lifetime tetanus vaccination
- Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (25)
Novartis Investigative Site
Aalst, 9300, Belgium
Novartis Investigative Site
Brussels, 1200, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Wilrijk, 2610, Belgium
Novartis Investigative Site
Nepean, Ontario, K2G 6E2, Canada
Novartis Investigative Site
Montreal, Quebec, H3A 2B4, Canada
Novartis Investigative Site
Sherbrooke, JiH 5N4, Canada
Novartis Investigative Site
Seinäjoki, 60220, Finland
Novartis Investigative Site
Turku, 20100, Finland
Novartis Investigative Site
Caen, 14033, France
Novartis Investigative Site
Rennes, 35043, France
Novartis Investigative Site
Saint-Herblain, 44800, France
Novartis Investigative Site
Toulouse, 31059, France
Novartis Investigative Site
Guatemala City, 01010, Guatemala
Novartis Investigative Site
Guatemala City, 01014, Guatemala
Novartis Investigative Site
Katowice, 40-594, Poland
Novartis Investigative Site
Lodz, 90-153, Poland
Novartis Investigative Site
Madrid, 28029, Spain
Novartis Investigative Site
Madrid, 28040, Spain
Novartis Investigative Site
Seville, 41009, Spain
Novartis Investigative Site
Valencia, 46009, Spain
Novartis Investigational Site
Basel, 4031, Switzerland
Novartis Investigative Site
Nottingham, NG7 2UH, United Kingdom
Novartis Investigative Site
Stoke-on-Trent, ST4 7LN, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2010
First Posted
September 13, 2010
Study Start
August 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 19, 2012
Results First Posted
June 19, 2012
Record last verified: 2012-05