EUCTR2010-018371-18-DE进行中（未招募）不适用
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 2010/2011 when administered to adult and elderly subjects
ovartis Vaccines and Diagnostics GmbH0 个研究点目标入组 126 人开始时间: 2010年3月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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.able to comply with all study requirements
- •3.in good health as determined by:
- •- medical history
- •- physical examination
- •- clinical judgment of the investigator
- •Informed consent must be obtained for all the subjects before enrollment into 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
- •1.Individuals with 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;
- •2.Individuals with any serious chronic or acute disease (in the judgment of the investigator), 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;
- •3.Individuals with 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, Polymyxin B;
- •4.Individuals with 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 parenteral or oral corticosteroid 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 derivates within the past 3 months and for the full length of the study;
- •d.suspected or known HIV infection or HIV-related disease;
- •5.Individuals with known or suspected history of drug or alcohol abuse;
- •6.Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject;
- •7.Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing age do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide),,intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry;
- •8.Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study;
- •9.Individuals that within the past 12 months have received more than one injection of influenza vaccine;
- •10.Individuals that within the past 6 months have:
- •a.had laboratory confirmed seasonal or pandemic influenza disease;
- •b.received seasonal or pandemic influenza vaccine;
- •11.Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
- •12.Individuals that have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days of intended study vaccination
- •13.Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
- •14.Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines
- •15.Individuals who have received blood, blood products and/or plasma derivatives or any parentera
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