Clinical trial NCT01199861: Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing multiple sclerosis
MS
Immune response
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Immune Response 3 Weeks After Seasonal Influenza Vaccination
timeFrame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)
Secondary outcomes:
measure: Immune Response 6 Weeks After Seasonal Influenza Vaccination
timeFrame: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).
measure: Immune Response 3 Weeks After Tetanus Toxoid Booster
timeFrame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)
measure: Immune Response 6 Weeks After Tetanus Toxoid Booster
timeFrame: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)
measure: Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination
timeFrame: Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).
measure: Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination
timeFrame: Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose of study drug until 45 days after the last dose of study drug (130 days).
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Nepean
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
city: Seinajoki
country: Finland
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: St Herblain
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigational Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Stoke-on-Trent
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: