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

Relapsing Multiple Sclerosis Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199861
• Other study ID #: CFTY720D2320
• Secondary ID: 2010-019028-30
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2010
• Last updated: May 15, 2012
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFinland: Finnish Medicines AgencyFRANCE: agence francaise de sécurité sanitaire des produits des santéGUATEMALA: Departamento de Regulación, y Control de Productos Farmacéuticos y AfinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fingolimod
Fingolimod 0.5 mg capsules for oral administration.
• Placebo
Matching placebo capsules for oral administration.

Biological:
• Seasonal influenza vaccine
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
• Tetanus toxoid vaccine
Commercially available tetanus toxoid vaccine booster injection.

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Wilrijk
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Nepean	Ontario
Canada	Novartis Investigative Site	Sherbrooke
Finland	Novartis Investigative Site	Seinajoki
Finland	Novartis Investigative Site	Turku
France	Novartis Investigative Site	Caen
France	Novartis Investigative Site	Rennes
France	Novartis Investigative Site	St Herblain
France	Novartis Investigative Site	Toulouse
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Lodz
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Sevilla
Spain	Novartis Investigative Site	Valencia
Switzerland	Novartis Investigational Site	Basel
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Stoke-on-Trent

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune Response 3 Weeks After Seasonal Influenza Vaccination	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)	Yes
Secondary	Immune Response 6 Weeks After Seasonal Influenza Vaccination	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).	Yes
Secondary	Immune Response 3 Weeks After Tetanus Toxoid Booster	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.	Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)	Yes
Secondary	Immune Response 6 Weeks After Tetanus Toxoid Booster	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.	Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)	Yes
Secondary	Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination	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).	Yes
Secondary	Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination	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).	Yes
Secondary	Number of Participants With Adverse Events (AEs)	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).	Yes