EUCTR2006-000787-88-GB进行中（未招募）1 期
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, when Administered to Non-Elderly Adult and Elderly Subjects - FLUVIRIN® 2006/2007 Seasonal Trial
Chiron Vaccines Limited0 个研究点目标入组 120 人开始时间: 2006年5月5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
- 入组人数
- 120
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 adult volunteers who are:
- •1.18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
- •2.able to comply with all the study requirements;
- •3.in general 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 in the study.
- •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
- •Individuals are not to be enrolled into the study if:
- •1.they have any serious disease such as:
- •· cancer (leukemia, lymphomas, neoplasm) except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy;
- •· autoimmune disease (including rheumatoid arthritis);
- •· advanced arteriosclerotic disease or insulin dependent diabetes mellitus;
- •· chronic obstructive pulmonary disease (COPD) that requires oxygen therapy;
- •· acute or progressive hepatic disease;
- •· acute or progressive renal disease;
- •· congestive heart failure;
- •2. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine;
- •3. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
- •4. they have 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 cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
- •· receipt of immunostimulants;
- •· receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
- •· suspected or known HIV infection or HIV-related disease;
- •5.they have a known or suspected history of drug or alcohol abuse;
- •6.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;
- •7.women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
- •8.within the past 12 months, they have:
- •· received more than one injection of influenza vaccine;
- •9.within the past 6 months, they have:
- •· had laboratory confirmed influenza disease;
- •· received influenza vaccine;
- •10.within the past 4 weeks they have received:
- •· another vaccine;
- •· any investigational agent;
- •11.within the past 7 days, they have experienced:
- •· any acute disease;
- •· infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
- •12.they have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days;
- •13.within the past 3 days, they have experienced:
- •· fever (i.e., body temperature = 38°C);
- •14.they are taking part in another clinical study;
- •15.they have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
研究者
相似试验
进行中（未招募）
1 期
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2007-2008, when Administered to Non-Elderly Adult and Elderly Subjects - FLUVIRIN® 2007/2008 seasonal trialProphylaxis of InfluenzaEUCTR2007-002063-27-GBovartis Vaccines and Diagnostics Limited126
进行中（未招募）
1 期
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® Surface Antigen, Inactivated Influenza Vaccine, Formulation 2005-2006, when administered to Non-Elderly Adult and Elderly SubjectsProphylaxis of influenzaEUCTR2005-000659-14-GBChiron Vaccines Limited100
进行中（未招募）
不适用
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® [Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur], Formulation 2008-2009, when Administered to Non-Elderly Adult and Elderly Subjects - FLUVIRIN® 2008-2009 seasonal trialProphylaxis of influenzaEUCTR2008-000939-17-GBovartis Vaccines and Diagnostics Limited
招募中
Unknown
study to explore diagnostic performance of [18F]fluoroestradiol (FES) positron emission tomography/computed tomography for the assessment of axillary lymph node metastasis in invasive lobular carcinoma of the breastKCT0008590Asan Medical Center30
进行中（未招募）
1 期
A study to Evaluate the Safety, Tolerability and Efficacy of an investigational drug Isavuconazonium Sulfate for the Treatment of Invasive Fungal InfectionsInvasive Aspergillosis and Invasive MucormycosisMedDRA version: 20.1Level: LLTClassification code 10062642Term: Invasive mycosisSystem Organ Class: 100000004862EUCTR2018-003975-36-BEAstellas Pharma Global Development, Inc.30