NCT01422512已完成3 期
A Phase III Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture, Formulation 2011/2012, When Administered to Adult and Elderly Subjects
Novartis Vaccines2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2011年9月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Antibody response as measured by hemagglutination inhibition (HI) assay
研究概览
简要总结
This study will evaluate safety and immunogenicity of surface, antigen, inactivated, influenza vaccine produced in mammalian cell culture when administered to adult and elderly subject.
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
- •Males and female volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry
- •Individuals able to comply with all the study requirements
- •Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
排除标准
- •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
- •Individuals with any serious chronic or acute disease including but not limited to: Medically significant Cancer , Medically significant advanced congestive heart failure (ie. NYHA class III and IV),Chronic obstructive pulmonary disease (COPD); Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years);Diabetes mellitus type I/II ;Advanced arteriosclerotic disease ;History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);Acute or progressive hepatic disease; Acute or progressive renal disease; Severe neurological or psychiatric disorder; Severe asthma
- •Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination
- •Individuals with known or suspected impairment/alteration of immune function 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
- •Individuals with known or suspected history of drug or alcohol abuse
- •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
- •Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential not planning to use acceptable birth control measures, for the whole duration of the study
- •Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
- •Individuals who within the past 6 months have had any seasonal or pandemic laboratory confirmed influenza disease
- •Individuals who have received any seasonal or pandemic influenza vaccine;
- •Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
- •Individuals who have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days of intended study vaccination
- •Individuals participating in another clinical trial
- •Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study
- •Individuals who are part of study personnel or close family members conducting this study
- •BMI > 35 kg/m2
结局指标
主要结局
Antibody response as measured by hemagglutination inhibition (HI) assay
时间窗: 22 days
Antibody response to each influenza antigen as measured by hemagglutination inhibition (HI) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines
次要结局
- Antibody response as measured by single radial hemolysis (SRH) assay(22 days)
- Number of subjects with solicited local and systemic reactions(7 days post vaccination)
研究者
研究点 (2)
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