Phase 3
Completed N=138
Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
Source: ClinicalTrials.gov NCT01199861 ↗Enrolled (actual)
138
Serious AEs
2.2%
Results posted
Jun 2012
Primary outcomePrimary: Immune Response 3 Weeks After Seasonal Influenza Vaccination — 53.3; 83.7 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune Response 3 Weeks After Seasonal Influenza Vaccination |
53.3; 83.7 | — |
| SECONDARY Immune Response 6 Weeks After Seasonal Influenza Vaccination |
43.2; 74.4 | — |
| SECONDARY Immune Response 3 Weeks After Tetanus Toxoid Booster |
40.0; 60.5 | — |
| SECONDARY Immune Response 6 Weeks After Tetanus Toxoid Booster |
37.5; 48.8 | — |
| SECONDARY Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination |
2.45; 4.14; 0.49; 0.36; 1.34; 2.40 | — |
| SECONDARY Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination |
1.81; 2.91; 0.36; 0.28; 1.08; 2.07 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
82; 34; 42; 11; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Must have relapsing MS
- Must have lifetime tetanus vaccination
- Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01199861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.