NCT00748813已完成2 期
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Sub
Novartis Vaccines6 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2008年6月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 6
- 主要终点
- Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21
研究概览
简要总结
Annual trial for registration influenza vaccine with the strain composition for season 2008/2009
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects eligible for enrollment into this study are male and female adults who are:
- •≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- •able to comply with all study requirements
- •in good health as determined by:
- •medical history
- •physical examination
- •clinical judgment of the investigator
排除标准
- •They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:
- •Cancer, except for localized skin cancer;
- •Advanced congestive heart failure;
- •Chronic obstructive pulmonary disease (COPD);
- •Autoimmune disease (including rheumatoid arthritis);
- •Acute or progressive hepatic disease;
- •Acute or progressive renal disease;
- •Severe neurological or psychiatric disorder;
- •Severe asthma.
- •They have 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, kanamycin and neomycin sulphate);
- •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 corticosteroid 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;
- •They have a known or suspected history of drug or alcohol abuse;
- •They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
- •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);
- •Within the past 12 months, they have:
- •received more than one injection of influenza vaccine
- •Within the past 6 months, they have:
- •had laboratory confirmed influenza disease;
- •received influenza vaccine;
- •Within the past 4 weeks they have received:
- •another vaccine;
- •any investigational agent;
- •They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days
结局指标
主要结局
Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21
时间窗: 21 days (-1/+5)
次要结局
- Evaluation of safety(21 days (-1/+5))
研究者
研究点 (6)
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