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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
138
Fingolimod 0.5 mg capsules for oral administration.
Matching placebo capsules for oral administration.
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Novartis Investigative Site
Aalst, Belgium
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.
Time frame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)
Immune Response 6 Weeks After Seasonal Influenza Vaccination
Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 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.
Time frame: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).
Immune Response 3 Weeks After Tetanus Toxoid Booster
Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met: 1. Seroconversion: The pre-vaccination antibody titer measurement was \<0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml. 2. Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.
Time frame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)
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Commercially available tetanus toxoid vaccine booster injection.
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
...and 15 more locations
Immune Response 6 Weeks After Tetanus Toxoid Booster
Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met: 1. Seroconversion: The pre-vaccination antibody titer measurement was \<0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml. 2. Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.
Time frame: 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
Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.
Time frame: 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
Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.
Time frame: Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).
Number of Participants With Adverse Events (AEs)
Relationship to study drug was determined by the investigator (suspected/not suspected). A serious AE is defined as an event which fulfills one of the following criteria: * is fatal or life-threatening; * results in persistent or significant disability/incapacity; * constitutes a congenital anomaly/birth defect; * requires inpatient hospitalization or prolongation of existing hospitalization; * is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above.
Time frame: From first dose of study drug until 45 days after the last dose of study drug (130 days).