A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to describe the immune response of FluMist compared with inactivated influenza vaccine in mild to moderately immunocompromised children with cancer
研究概览
简要总结
Eligible research subjects will be randomized to receive either FluMist or inactivated influenza vaccine then stratified by age and necessity to receive either one or two immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed for 30 minutes following vaccination and given a diary card to record symptoms after each vaccination.
详细描述
The secondary objectives of this study are to:
- Describe the safety of FluMist and inactivated influenza vaccine.
- Describe the incidence and duration of viral replication following immunization with FluMist.
- To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 through 21 (not yet reached their 22nd birthday) at the time of entry into the study
- •Participant or participants parent/legal guardian available by telephone during the course of the study;
- •Written informed consent (and assent, if applicable) obtained
- •Currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or have received chemotherapy in the past 12 weeks;
- •If the participant's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the participant's underlying disease is a hematological malignancy, current status must be in remission, and if receiving chemotherapy, must be in the "continuation" or "maintenance" phase of therapy or equivalent;
- •Estimated life expectancy of > 1 year
排除标准
- •History of hypersensitivity to any component of FluMist or TIV, including egg or egg products, gelatin, or monosodium glutamate;
- •History of hypersensitivity to gentamicin;
- •Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment
- •History of Guillain-Barre´ syndrome;
- •History of asthma;
- •Female who is breastfeeding or lactating;
研究组 & 干预措施
2
干预措施: Inactivated influenza vaccine (Biological)
1
干预措施: FluMist (Biological)
结局指标
主要结局
The primary objective of this study is to describe the immune response of FluMist compared with inactivated influenza vaccine in mild to moderately immunocompromised children with cancer
时间窗: 6 months
次要结局
- Immunization response(10/31/2010)
- Flumist safety(2 years)
- Viral Replication(1 year)