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

May 15, 2012 updated by: Novartis

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
      • Wilrijk, Belgium, 2610
        • Novartis Investigative Site
  • Canada
      • Sherbrooke, Canada, JiH 5N4
        • Novartis Investigative Site
    • Ontario
      • Nepean, Ontario, Canada, K2G 6E2
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Novartis Investigative Site
  • Finland
      • Seinajoki, Finland, 60220
        • Novartis Investigative Site
      • Turku, Finland, 20100
        • Novartis Investigative Site
  • France
      • Caen, France, 14033
        • Novartis Investigative Site
      • Rennes, France, 35043
        • Novartis Investigative Site
      • St Herblain, France, 44800
        • Novartis Investigative Site
      • Toulouse, France, 31059
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Novartis Investigative Site
      • Guatemala City, Guatemala, 01014
        • Novartis Investigative Site
  • Poland
      • Katowice, Poland, 40-594
        • Novartis Investigative Site
      • Lodz, Poland, 90-153
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28040
        • Novartis Investigative Site
      • Madrid, Spain, 28029
        • Novartis Investigative Site
      • Sevilla, Spain, 41009
        • Novartis Investigative Site
      • Valencia, Spain, 46009
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigational site
  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • Novartis Investigative Site
      • Stoke-on-Trent, United Kingdom, ST4 7LN
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fingolimod
Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
Drug: Fingolimod
Fingolimod 0.5 mg capsules for oral administration.
Other Names:
  • FTY720
Biological: Seasonal influenza vaccine
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Other Names:
  • Agrippal (TM)
Biological: Tetanus toxoid vaccine
Commercially available tetanus toxoid vaccine booster injection.
Other Names:
  • Tetanol (TM)
Placebo Comparator: Placebo
Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
Biological: Seasonal influenza vaccine
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Other Names:
  • Agrippal (TM)
Biological: Tetanus toxoid vaccine
Commercially available tetanus toxoid vaccine booster injection.
Other Names:
  • Tetanol (TM)
Drug: Placebo
Matching placebo capsules for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Response 3 Weeks After Seasonal Influenza Vaccination
Time Frame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)

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.
Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune Response 6 Weeks After Seasonal Influenza Vaccination
Time Frame: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).

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.
Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).
Immune Response 3 Weeks After Tetanus Toxoid Booster
Time Frame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)

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.
Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)
Immune Response 6 Weeks After Tetanus Toxoid Booster
Time Frame: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)

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.
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
Time Frame: Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).
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.
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
Time Frame: Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).
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.
Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose of study drug until 45 days after the last dose of study drug (130 days).

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.
From first dose of study drug until 45 days after the last dose of study drug (130 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D2320
  • 2010-019028-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsing Multiple Sclerosis

Clinical Trials on Fingolimod

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe