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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Immune Response 3 Weeks After Seasonal Influenza Vaccination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have relapsing MS
- •Must have lifetime tetanus vaccination
- •Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Fingolimod (Drug)
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.
干预措施: Seasonal influenza vaccine (Biological)
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.
干预措施: Tetanus toxoid vaccine (Biological)
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.
干预措施: Placebo (Drug)
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.
干预措施: Seasonal influenza vaccine (Biological)
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.
干预措施: Tetanus toxoid vaccine (Biological)
结局指标
主要结局
Immune Response 3 Weeks After Seasonal Influenza Vaccination
时间窗: 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.
次要结局
- Number of Participants With Adverse Events (AEs)(From first dose of study drug until 45 days after the last dose of study drug (130 days).)
- Immune Response 3 Weeks After Tetanus Toxoid Booster(Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9))
- Immune Response 6 Weeks After Seasonal Influenza Vaccination(Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).)
- Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination(Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).)
- Immune Response 6 Weeks After Tetanus Toxoid Booster(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(Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).)