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

NCT01199861 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2012-06-19

Study results available
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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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Belgium
  • Canada
  • Finland
  • France
  • Guatemala
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01199861 on ClinicalTrials.gov