NCT01031719已完成3 期
A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors
研究概览
简要总结
This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Solid Invasive Tumors and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.
Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.
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
- None
入排标准
- 年龄范围
- 2 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Invasive Solid Tumor Subjects:
- •Subjects between 2 and 70 years of age (inclusive)
- •Any sex or ethnicity
- •Confirmed diagnosis of Invasive Solid Tumor or hematological malignancies in complete remission for at least 3 months and not more than 18 months after the last neo-adjuvant and/or adjuvant chemotherapy cycle according to investigators assessment and the subjects medical records
- •Previous use of neo-adjuvant and/or adjuvant chemotherapy for the treatment on an invasive solid tumor
- •Life expectancy of at least 12 months
- •Karnofsky Performance Scale > 40%
- •Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
- •Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
- •Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole intercourse
- •Intra-uterine device (IUD)
- •Monogamous relation with vasectomized partner (must have been vasectomized at least six months before the volunteer entered the study).
- •Subjects capable of following all the study procedures and available for all visits scheduled to the investigation site
- •Subjects capable of understanding the nature and risk of the study proposed and sign the consent form
- •In case of children and adolescents (below 18 years of age): Subjects capable of understanding the nature of the study and whose legal guardian understands the nature and risk of the study proposed and signs the consent form
- •The study subjects may have other underlying chronic diseases that do not involve immunosuppression (e.g. osteoarticular diseases, cardiorespiratory diseases, metabolic diseases, stable, non progressive, non-severe neurologic disorders without cognitive impairment, ophthalmologic diseases, etc.), but their symptoms/signs must be under control through medical follow-ups and drug therapy
- •For Healthy Subjects:
- •Subjects between 2 and 70 years of age (inclusive)
- •Any sex and ethnicity
- •Subjects with good health as determined by medical history, physical evaluation, and investigator's clinical opinion
- •Childbearing potential women must be willing to use an acceptable contraceptive method. Acceptable contraceptive methods are defined as one or more of the following:
- •Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous implant, cervical ring)
- •Barrier (condom with spermicide or diaphragm with spermicide) at each intercourse and during the whole sexual intercourse
- •Intra-uterine device (IUD)
- •Monogamous relation with vasectomized partner (must have been vasectomized for at least six months before the volunteer entered the study).
- •Subjects capable of respecting all the study procedures and available for all the visits scheduled at the investigation site
- •Subjects capable of understanding the nature and risk of the study proposed and sign the consent form
- •In case of children and adolescents (below 18 years of age): Subjects capable of understanding the nature of the study and whose legal guardian understands the nature and risk of the study proposed and signs the consent form
排除标准
- •For Invasive Solid Tumor Subjects:
- •Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus
- •Administration of other vaccine against the novel H1N1 virus within 3 months prior to inclusion in the study
- •Any recent vaccine given within the last 21 days (inclusive)
- •History of allergic reaction to an influenza vaccine in the past, or a current or previous occurrence of allergy to egg or egg protein, kanamycin, and neomycin sulfate
- •Acute febrile disease (vaccination may be delayed up to 3 days after the resolution of the symptoms)
- •Presence of other diseases, not related to cancer with confirmed immunosuppression
- •Chemotherapy, biologic therapy or radiation within 3 months prior to inclusion in the study
- •History of chronic hepatic or renal disease
- •History of cognitive disorders
- •History of progressive or severe neurological disorders, including Guillain-Barré Syndrome
- •Pregnancy or breast-feeding
- •Use of immunomodulatory therapy, including cyclosporin, interleukins, and interferons, within 3 months prior to inclusion in the study
- •Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3 months prior to inclusion in the study
- •Receipt of any investigational product within 12 months prior to inclusion in the study
- •For Healthy Subjects:
- •Previous laboratory confirmed diagnosis of an infection by the new virus H1N1
- •Receipt of another vaccine against the new virus H1N1 within 3 months prior to inclusion in the study
- •Any recent vaccine given within the last 21 days (inclusive)
- •History of allergic reaction to influenza vaccine in the past, or a current or previous allergy to egg or egg protein, kanamycin, and neomycin sulfate;
- •Acute febrile disease (the vaccination may be delayed up to 3 days after symptoms resolution)
- •Pregnancy or breast-feeding
- •Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3 months prior to inclusion in the study;
- •Receipt of any investigational product within 12 months prior to inclusion in the study
研究组 & 干预措施
Group A: High Risk Population
Experimental
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
干预措施: adjuvanted A(H1N1) influenza vaccine (Biological)
Group B: High Risk Subjects
Experimental
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
干预措施: non-adjuvanted A(H1N1) influenza vaccine (Biological)
Group C: Healthy Subjects
Experimental
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
干预措施: adjuvanted A(H1N1) influenza vaccine (Biological)
Group D: Healthy Subjects
Experimental
Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22
干预措施: non-adjuvanted A(H1N1) influenza vaccine (Biological)
结局指标
主要结局
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors
时间窗: 3 months
次要结局
- Assess whether the adjuvanted vaccine offers a meaningful benefit in relation to the non-adjuvanted vaccine in this at-risk population(3 months)
- Assess whether two doses of either study vaccine will provide meaningful benefit in comparison to one dose(3 months)
- Assess the persistence of antibody levels in the two vaccine groups(3 months)
- Gain further insight into the safety of the adjuvanted and non-adjuvanted H1N1 vaccines in this high-risk patient population(3 months)
研究者
研究点 (3)
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