NCT01695733终止1 期
Influenza Vaccination Response in Patients With Non-Hematological Malignancies
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.
研究概览
简要总结
This clinical trial studies the best time to administer the influenza vaccine to patients with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different times relative to chemotherapy may affect how well it works to help the body build an immune response and prevent influenza in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have biopsy-confirmed non-hematological malignancy
- •Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy
- •Patients must be of age >=18 years.
- •Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to influenza vaccination
- •Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have already received the influenza vaccine during the season in which they are considered for eligibility will be excluded
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies
- •Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination
- •Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless used as part of a chemotherapy regimen
- •Patients must not be on any other agents that can suppress the immune system
- •Planned concurrent therapy with radiation
- •Uncontrolled illness at time of enrollment or influenza vaccination including, but not limited to, ongoing or active febrile illness
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Known immunosuppression eg. history of organ transplantation or known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because they may not be able to mount an appropriate immune response
- •History of influenza-like illness, defined as a temperature > 37.8 degree C with cough or sore throat starting October 1, 2011 throughout the duration of the study
- •Patient may not be scheduled to receive chemotherapy on a weekly basis.
研究组 & 干预措施
Schedule B
Experimental
Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy
干预措施: trivalent influenza vaccine (Biological)
Schedule A
Experimental
Influenza vaccination on the first day of chemotherapy
干预措施: trivalent influenza vaccine (Biological)
结局指标
主要结局
Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.
时间窗: 4 weeks from the influenza vaccine
We will assess co-primary endpoints of serologic response to the H3N2 and H1N1 strains in the 2011-2012 and 2012-2013 seasonal influenza vaccine.
次要结局
- Report the presence of post-vaccination adverse events(4 weeks from the influenza vaccine)
研究者
研究点 (1)
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