EUCTR2008-000887-18-DE进行中（未招募）1 期
A Phase III, multicenter, uncontrolled, open-label study to evaluate safety and immunogenicity of Begrivac®, preservative free, inactivated split influenza vaccine, using the strain composition 2008/2009 when administered to adult and elderly subjects
ovartis Vaccines and Diagnostics GmbH & Co KG0 个研究点目标入组 126 人开始时间: 2008年3月25日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
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
- •Subjects eligible for enrollment into this study are male and female adults who are
- •1.= 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- •2.available for all the visits scheduled in the study and able to comply with all study requirements
- •3.in good health as determined by:
- •- medical history
- •- physical examination
- •- clinical judgment of the investigator
- •Written informed consent must be obtained from all the subjects before enrollment in the study after the nature of the study has been explained.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
- •1.They Have any serious (in the judgment of the investigator) disease, including but not limited to:
- •a.Cancer, except for localized skin cancer
- •b.Advanced congestive heart failure
- •c.Chronic obstructive pulmonary disease (COPD)
- •d.Autoimmune disease (including rheumatoid arthritis)
- •e.Acute or progressive hepatic disease
- •f.Acute or progressive renal disease
- •g.Severe neurological or psychiatric disorder
- •h.Severe Asthma
- •2.They have a history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).
- •3.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:
- •a.receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
- •b.Receipt of immunostimulants,
- •c.Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
- •d.Suspected or known HIV infection or HIV-related disease.
- •4.Known or suspected history of drug or alcohol abuse.
- •5.They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject;
- •6.Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days).
- •7.Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
- •8.Within the past 4 weeks they have received:
- •-another vaccine
- •-any investigational agent;
- •9.Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
- •10.They have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days
- •11.Simultaneous participation in another clinical study.
- •12.Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
- •13.Severely obese with Body Mass Index (BMI) > 35
- •14.Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
研究者
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