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Completed

NCT Number: 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)

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.

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Key information

Conditions

Relapsing Multiple Sclerosis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fingolimod

Drug

Fingolimod 0.5 mg capsules for oral administration.

Other names: FTY720

Placebo

Drug

Matching placebo capsules for oral administration.

Seasonal Influenza Vaccine

Biological

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

Other names: Agrippal (TM)

Tetanus toxoid vaccine

Biological

Commercially available tetanus toxoid vaccine booster injection.

Other names: Tetanol (TM)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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:

    • Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.
    • 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.

  3. 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:

    • Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.
    • 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2010
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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