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

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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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