A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
研究概览
简要总结
The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old to less than 65 years old
- •Subjects with malignancy must be receiving chemotherapy
- •Medically stable
- •Able to understand and willingness to sign a written informed consent
- •Able to comply with study procedures
- •Life expectancy of more than 3 months
- •Adequate organ function:
- •ANC >1000/mm3
- •Platelet >100,000/uL
- •Creatinine <2 mg/dL
- •AST and ALT <3 times the ULN
排除标准
- •Allergy to eggs
- •Prior allergy to Influenza Vaccine
- •History of Guillain-Barre Syndrome
- •Current febrile illness
- •Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV)
- •Autologous or Allogenic Stem Cell Transplant with in a year
- •Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)
结局指标
主要结局
The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
时间窗: Baseline and 28 days
Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
次要结局
- Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.(7 days)
- The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.(28 days)
- Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.(7 days)
- The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.(Baseline and 28 days)
- Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.(28 days)
研究者
Saad Jamshed MD
Principal Investigator
Rochester General Hospital