EUCTR2007-000963-28-GB进行中（未招募）1 期
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1® Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2007-2008, when Administered to Non-Elderly Adult and Elderly Subjects - Agrippal seasonal trial
ovartis Vaccines and Diagnostics S.r.l0 个研究点目标入组 126 人开始时间: 2007年6月14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
- 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 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 into 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, kanamycin and neomycin sulphate 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., axillary 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.
- •16. Women who are breast feeding.
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