EUCTR2013-000545-39-BE进行中（未招募）1 期
A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus Vaccine (Agrippal®) in Healthy Adults
ovartis Vaccines and Diagnostics S.r.l.0 个研究点开始时间: 2013年3月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to participate in this study, a subject must meet ALL of the following inclusion
- •? Is a male or female volunteer ages 18 years or older, mentally competent, willing
- •and able to give written informed consent prior to study entry;
- •? Is able to comply with all the study requirements; and
- •? Is in good health as determined by the outcome of medical history, physical
- •examination, and clinical judgment of the investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
排除标准
- •In order to participate in this study, a subject must not meet any of the following exclusion criteria:
- •? Has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject’s ability to participate in the study;
- •? Has a serious chronic or acute disease (in the judgment of the investigator) including, but not limited to
- •- medically significant cancer (except for benign or localized skin cancer, cancer in remission for =10 years, or localized prostate cancer that has been clinically stable for >2 years without treatment)
- •- medically significant advanced congestive heart failure (ie, New York Heart Association [NYHA] class III and IV)
- •- chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease [GOLD] stage III and IV)
- •- autoimmune disease (including rheumatoid arthritis and excepting Hashimoto’s thyroiditis that has been clinically stable for =5 years)
- •- diabetes mellitus type I
- •- poorly controlled diabetes mellitus type II
- •- advanced arteriosclerotic disease
- •- history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (eg, Down’s syndrome)
- •- acute or progressive hepatic disease
- •- acute or progressive renal disease
- •- severe neurological (especially Guillain–Barré syndrome) or psychiatric disorder
- •- severe asthma
- •? Has a history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine (see section 5.1);
- •? Has a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
- •- receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study,
- •- receipt of immunostimulants within the past 6 months,
- •- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within the past 3 months and for the full length of the study, or
- •- suspected or known human immunodeficiency virus (HIV) infection or HIV related disease
- •? Has known or suspected drug or alcohol abuse within the past 2 years;
- •? Has bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator’s opinion, would interfere with the safety of the subject;
- •? Is not able to comprehend and to follow all required study procedures for the whole period of the study;
- •? Has a history or any illness that, in the opinion of the investigator, would pose additional risk to the subjects because of participation in the study;
- •? Has the following within the past 6 months:
- •- had any laboratory confirmed seasonal or pandemic influenza disease
- •- received any seasonal or pandemic influenza vaccine
- •? Has received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study;
- •? Has acute or chronic infections requiring antiviral therapy within the last 7 days;
- •? Has experienced fever (ie, body temperature [preferably oral] =38.0°C) within the last 3 days of intended study vaccination;
- •? Has been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of
研究者
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