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

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Novartis

Status and phase

Completed
Phase 3

Conditions

Relapsing Multiple Sclerosis

Treatments

Biological: Tetanus toxoid vaccine
Biological: Seasonal influenza vaccine
Drug: Placebo
Drug: Fingolimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT01199861
CFTY720D2320
2010-019028-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

138 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

138 participants in 2 patient groups, including a placebo group

Fingolimod
Experimental group
Description:
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.
Treatment:
Drug: Fingolimod
Biological: Seasonal influenza vaccine
Biological: Tetanus toxoid vaccine
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo
Biological: Seasonal influenza vaccine
Biological: Tetanus toxoid vaccine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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