Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)

PHASE3CompletedINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Relapsing Multiple Sclerosis
Interventions
DRUG

Fingolimod

Fingolimod 0.5 mg capsules for oral administration.

DRUG

Placebo

Matching placebo capsules for oral administration.

BIOLOGICAL

Seasonal influenza vaccine

Commercially available injectable influenza vaccine for the 2010/11 influenza season.

BIOLOGICAL

Tetanus toxoid vaccine

Commercially available tetanus toxoid vaccine booster injection.

Trial Locations (25)

1200

Novartis Investigative Site, Brussels

2610

Novartis Investigative Site, Wilrijk

3000

Novartis Investigative Site, Leuven

4000

Novartis Investigative Site, Liège

4031

Novartis Investigational Site, Basel

9300

Novartis Investigative Site, Aalst

14033

Novartis Investigative Site, Caen

20100

Novartis Investigative Site, Turku

28029

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

31059

Novartis Investigative Site, Toulouse

35043

Novartis Investigative Site, Rennes

41009

Novartis Investigative Site, Seville

44800

Novartis Investigative Site, Saint-Herblain

46009

Novartis Investigative Site, Valencia

60220

Novartis Investigative Site, Seinäjoki

K2G 6E2

Novartis Investigative Site, Nepean

H3A 2B4

Novartis Investigative Site, Montreal

JiH 5N4

Novartis Investigative Site, Sherbrooke

01010

Novartis Investigative Site, Guatemala City

01014

Novartis Investigative Site, Guatemala City

40-594

Novartis Investigative Site, Katowice

90-153

Novartis Investigative Site, Lodz

NG7 2UH

Novartis Investigative Site, Nottingham

ST4 7LN

Novartis Investigative Site, Stoke-on-Trent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

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) | Biotech Hunter | Biotech Hunter